Patient Safety Advisory Produced by ECRI under contract to the Patient Safety Authority Vol. 2, Sup. 1—Apr 21, 2005 SUPPLEMENTARY ADVISORY Convenience at a Cost Changing Catheters Over a Wire Reports submitted to PA-PSRS from the same hos- pital within an eight-day period concerned pieces of intravenous catheters being left in patients and em- bolizing. Two events were discovered following CT scans, with the catheter segments lodged in one patient’s inferior vena cava and another patient’s hepatic vessels. Subsequent to each occurrence, the retained catheter segments were removed with interventional angiography. Following root cause analysis, the hospital staff de- termined that a resident physician was cutting the sheath introducer of single lumen infusion catheters to facilitate change to a new catheter using the Seldinger technique over a wire. The resident did not realize that there was a separate inner catheter inside the outer sheath introducer in the single lu- men catheter. When the guidewire was introduced Figure 2 shows the catheter inserted further into the into the cut end of the sheath introducer, it pushed introducer to the point where the catheter hub is the cut end of the inner catheter into the blood resting against the introducer hub. stream without the physician’s awareness. The hospital acted quickly to stop the practice of modify- The sheath introducer hub acts as a stop for the ing the catheters in this manner and reported the catheter and, on some models, provides a mecha- events and their analysis to PA-PSRS. nism to lock the catheter to the introducer to pre- vent unintentional catheter movement. Cutting An intravenous infusion catheter is placed, usually in a large central vein, to administer various intrave- nous fluids and agents. A percutaneous sheath in- troducer is used to insert and maintain the catheter placement in a vessel. Figure 1 shows the catheter inserted into the introducer. The side port of the sheath introducer is used to infuse fluids into the bloodstream. According to the facility, a resident physician was unfamiliar with this particular type of catheter and did not realize that cutting the outer sheath introdu- cer below its hub also cut an inner catheter, freeing it from its hub. Confusion may be compounded by the fact that when the hub of the catheter is posi- tioned against the hub of the sheath introducer; the sheath and catheter may appear as a single device. Vol. 2, Sup. 1—Apr. 21, 2005 ©2005 Patient Safety Authority Page 1 PA-PSRS Patient Safety Advisory Convenience at a Cost (Continued) below the hub of the sheath introducer removes this further into the sheath introducer, the inner cathe- anchor. Figure 3a shows where a cut might be ter is pushed further distally into the patient’s made below the hub of the introducer and catheter bloodstream. assembly to introduce a new catheter. A Seldinger guidewire inserted into the introducer to guide the The cases described above would not be exclu- placement of a new catheter into the vein pushes sive to a specific style or model sheath introducer the free-floating original piece of infusion catheter and catheter, but could occur with any style or into the patient’s bloodstream. The small arrows in model. Figure 3b show that when the guidewire is pushed Oxygen Flow Selector on a green locating arrow pointing at the port. Each Two reports, each from different healthcare facili- of the two inactive ports is indicated with the word ties, were submitted to PA-PSRS involving uninten- “OFF” printed on red locating arrows pointing at tional failure to deliver oxygen therapy to patients each port. The user turns the flow selector control due to misconfiguration of the oxygen (O2) flow se- knob to the appropriate outflow port. lector device. In one report, on routine assessment, the patient was discovered with an O2 saturation According to Precision Medical’s marketing litera- level of 83% and with “dusky blue-color” extremities. ture, the flow selector features allow a humidifier to In the other report, one of the patient’s family mem- remain connected during nebulizer treatments and bers notified a nurse that the patient was “a little tubing to remain connected when not in use to save confused.” In both cases, the patients stabilized time and reduce clutter. once O2 flow was reestablished. In 1997, Precision Medical Inc and Medical Fittings, Of the two reports, one identified the manufacturer Inc., initiated product recalls (FDA Recall Nos. Z- and model flow selector involved in the incident as 824/825-7, ECRI Health Devices Alerts Action Item Precision Medical Inc Model PM 1000 Flow Selector No. A3336) on flow selector models PM1000 and also marketed as Model MF8025 by Medical Fit- MF8025, respectively. The recall was based on tings, Inc, a subsidiary of Precision Medical. This FDA’s determination that labeling for the flow selec- particular flow selector has a threaded female con- tors was inadequate. New labeling was provided by nection for a standard O2 flowmeter. Once con- Precision Medical and approved by FDA. Until new nected to the flowmeter, the flow of O2 can be di- labeling was received by healthcare facilities, the rected to only one of three outflow ports on the de- products were deemed safe to use, provided users vice; one DISS outflow and two tubing connections. were aware that only one outflow port was active at A label on the flow selector control knob indicates a time. the selected active port with the word “ON” printed Page 2 ©2005 Patient Safety Authority Vol. 2, Sup. 1—Apr. 21, 2005 PA-PSRS Patient Safety Advisory Convenience at a Cost (Continued) A search of FDA’s Manufacturer and User Facility but one of convenience for the clinical user. Based Device Experience (MAUDE) database from the on the two PA-PSRS reports, the MAUDE reports, year 2000 to the present, using the keyword search and the 1997 safety recall, convenience still comes “flow selector” revealed 9 reports, for Models at a potential cost to patient safety. To avoid similar PM1000 and MF8025, of improper flow selector occurrences, some hospitals have removed the setup or failure of the flow selector to deliver O2 to flow selectors from service or educated clinical staff the appropriate outflow port. Currently, we are un- on the proper operation of the device and on the aware of similar flow selector products marketed for need to verify that O2 is flowing to the patient prior sale to healthcare facilities. to leaving the patient’s room. The flow selector device does not appear to be de- signed to provide a clinical benefit for the patient, Vol. 2, Sup. 1—Apr. 21, 2005 ©2005 Patient Safety Authority Page 3 PA-PSRS Patient Safety Advisory An Independent Agency of the Commonwealth of Pennsylvania The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI, as contractor for the PA-PSRS program, is issuing this newsletter to advise medical facilities of immediate changes that can be instituted to reduce serious events and incidents. For more information about the PA- PSRS program or the Patient Safety Authority, see the Authority’s website at www.psa.state.pa.us. ECRI is an independent, nonprofit health services research agency dedicated to improving the safety, efficacy and cost-effectiveness of healthcare. ECRI’s focus is healthcare technology, healthcare risk and quality management and healthcare environmental management. ECRI provides information ser- vices and technical assistance to more than 5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies, and other organizations worldwide. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, govern- ment agencies, accrediting organizations, and consumers. ISMP's efforts are built on a non-punitive approach and systems-based solutions. The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. The Patient Safety Advisory (ISSN 1552-8596) is published quarterly, with periodic supplements, for the Pennsylvania Patient Safety Reporting System (PA-PSRS) to advise medical facilities of immediate changes that can be instituted to reduce serious events and incidents. This publication can be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. Copyright 2005 by the Pennsylvania Patient Safety Authority. For more information about the PA-PSRS program or the Patient Safety Authority, see the Authority’s website at www.psa.state.pa.us Page 4 ©2005 Patient Safety Authority Vol. 2, Sup. 1—Apr. 21, 2005