BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFECARE PCA 3 V5.06

    MDR report key: 1760716 · Received July 15, 2010

    Report

    Report Number
    2921482-2010-00521
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 17, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE PUMP HISTORY WAS DOWNLOADED AT THE MANUFACTURING FACILITY. A REVIEW OF THE PUMP HISTORY INDICATED THAT ON (B)(6) 2010 AT 0932, THE PUMP WAS POWERED ON, THE HISTORY WAS CLEARED, A CUSTOM VIAL WAS CONFIRMED AND THE PUMP WAS PROGRAMMED AND CONFIRMED TO DELIVER A DRUG CONCENTRATION OF 1MG/ML IN THE PCA ONLY MODE, WITH A 0.1MG PCA DOSE, WITH AN 8MIN PATIENT LOCKOUT, NO DOSE LIMIT WAS SELECTED WHICH CORRELATED TO THE CUSTOMER'S REPORTED PROGRAMMING. THE DOOR WAS LOCKED. BETWEEN 1135 AND 1137, THE DOOR WAS OPENED AND CLOSED TWO TIMES, THERE WAS A CHECK VIAL ALARM, 2 CHECK SYRINGE ALARMS, 2 CHECK INJECTOR ALARMS, A BAR CODE NOT READ ALARM, 2 CONFIRM ALPHA VIAL, ONE CHECK SETTINGS ALARM, THE SETTINGS WERE RETAINED, AND THE PUMP WAS REPROGRAMMED USING THE SAME PROGRAMMING PARAMETERS AND THE SETTINGS CONFIRMED. BETWEEN 1226 AND 1228, THE DOOR WAS OPENED AND LOCKED, THERE WAS A CHECK VIAL ALARM, CHECK SYRINGE ALARM, AN ALPHA VIAL WAS CONFIRMED, SETTINGS RETAINED, AND THE PUMP WAS REPROGRAMMED USING THE SAME PROGRAMMING PARAMETERS, AND THE SETTINGS WERE CONFIRMED. BETWEEN 1234 AND 0109, THE DOOR WAS OPENED TWICE AND LOCKED ONCE, THERE WERE 2 CHECK VIAL ALARMS, AN ALPHA VIAL CONFIRMED TWICE, A CHECK SYRINGE ALARM, THE SETTINGS RETAINED, THE PUMP WAS REPROGRAMMED USING THE SAME PROGRAMMING PARAMETERS, THE SETTINGS WERE CONFIRMED, AND THE PUMP WAS POWERED OFF. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN ADVERSE PATIENT EVENT WHILE THE PUMP WAS IN CLINICAL USE. AT 0930, THE PUMP WAS PROGRAMMED IN THE PCA ONLY MODE TO DELIVER DILAUDID 1MG/ML, WITH A 0.1MG PCA DOSE, AN 8MIN PATIENT LOCKOUT, AND NO DOSE LIMIT SELECTED. THE CUSTOMER CONTACT REPORTED THAT AT THIS TIME, TWO NURSES CONFIRMED THE PROGRAMMED SETTINGS. AT 1130, FOLLOWING SURGERY, THE PATIENT WAS TRANSFERRED TO THE MEDICAL SURGICAL UNIT. DURING THE NURSING ASSESSMENT, IT WAS REPORTED THAT THE PATIENT'S RESPIRATORY RATE WAS 18 BREATHS/MIN WITH A 94% OXYGEN SATURATION LEVEL ON ROOM AIR. IT WAS REPORTED THAT THE PATIENT WAS ORIENTED, CONVERSING, AND SLIGHTLY SLEEPY, BUT EASILY AROUSABLE. AT THIS TIME, THE NURSE NOTED 5ML OF AIR WAS AT THE TOP OF THE PCA VIAL INSIDE THE LOCKED PUMP AND THE PUMP DISPLAY INDICATED THAT 0.0MG HAD BEEN DELIVERED. AT THIS TIME, THE NURSE CLAMPED THE PCA TUBING SET WITHOUT DISCONNECTING THE TUBING FROM THE PATIENT, REMOVED THE VIAL FROM THE PUMP, VERIFIED 5ML OF AIR WAS IN THE VIAL, RELOADED THE VIAL IN THE PUMP, AND NOTIFIED THE CHARGE NURSE. AT 1230, THE CHARGE NURSE AND STAFF NURSE REMOVED THE VIAL FROM THE PUMP WHILE BOTH CLAMPING AND PINCHING THE TUBING SET AND VERIFIED 5ML OF AIR IN THE VIAL. THE CUSTOMER CONTACT REPORTED THAT AT THIS TIME, THE TUBING SET WAS AGAIN NOT DISCONNECTED FROM THE PATIENT. THE CLINICAL PHARMACIST WAS NOTIFIED. AT AN UNSPECIFIED TIME, THE NURSES NOTED THAT THE PATIENT HAD A RESPIRATORY RATE OF 12 BREATHS/MINUTE, AN 86% OXYGEN SATURATION LEVEL ON ROOM AIR, AND THE PATIENT WAS UNRESPONSIVE. A STERNAL RUB WAS PERFORMED WITH MINIMAL RESPONSE. THE NURSE INITIATED OXYGEN AT A RATE OF 2L/MIN VIA NASAL CANNULA. AT 1235, THE CLINICAL PHARMACIST ENTERED THE PATIENT'S ROOM AND VERIFIED THE PUMP INDICATED THAT 0.0MG HAD BEEN DELIVERED AND THERE WAS 5ML OF AIR AT THE TOP OF THE PCA VIAL. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. A REPLACEMENT PUMP WAS OBTAINED; HOWEVER, THE THERAPY WAS NOT RESUMED. THE PHYSICIAN WAS NOTIFIED. AT 1355, THE PATIENT WAS TREATED WITH 0.2MG OF NARCAN. THE CUSTOMER CONTACT REPORTED ALMOST IMMEDIATELY, THE PATIENT WAS AWAKE, WITH A 97% OXYGEN SATURATION LEVEL, AND "WAS SITTING UP IN BED WONDERING WHAT WAS GOING ON." AT 1530, IT WAS REPORTED THAT THE PATIENT WAS "GROGGY AGAIN AND SLURRING HER SPEECH." AT THIS TIME, THE PATIENT WAS TREATED WITH 0.2MG NARCAN. THE CUSTOMER REPORTED THE PATIENT "WOKE UP FOR A PERIOD OF TIME." AT 1630, THE PATIENT WAS TREATED WITH 0.2MG NARCAN. AT 1700, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR CLOSER MONITORING. AT 1801, THE PATIENT WAS TREATED WITH 0.4MG NARCAN. THE PATIENT REMAINED IN THE INTENSIVE CARE UNIT FOR 24 HOURS AND WAS TRANSFERRED BACK TO THE MEDICAL SURGICAL UNIT FOR POST OPERATIVE CARE AND PHYSICAL THERAPY RELATED TO THE SURGICAL PROCEDURE. THE CUSTOMER REPORTED THAT AFTER THE EVENT, THE NURSES WASTED A TOTAL OF 23ML FROM THE VIAL. THE CUSTOMER CONTACT STATED THAT THE STAFF REALLY DID NOT KNOW WHAT WAS GOING ON WITH THE PATIENT AND DIDN'T KNOW IF THE PATIENT HAD ACTUALLY RECEIVED THE MISSING DILAUDID; THEREFORE, THE PATIENT WAS TREATED WITH THE ADDITIONAL DOSES OF NARCAN. THE CUSTOMER CONTACT STATED THAT THE "AMOUNT OF NARCAN GIVEN WAS NOT NECESSARILY 100% CONTRIBUTABLE TO THE DILAUDID" AND THE PATIENT WAS REPORTED AS NARCOTIC NAÏVE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PCA 3 V5.06 80MEA MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R GIVEN OVER A DURATION OF 4 HOURS| BUPIVICAINE 0.5% 2.2ML SPINAL| INTRAOPERATIVE MEDICATIONS: PROPOFOL WITH 34.4ML| VANCOMYCIN 1GM AND| WOUND IRRIGATION OF BACITRACIN WITH EPINEPHRINE| HOSPIRA PCA VIAL LIST #6021 LOT #82520| DILAUDID| MANUFACTURED BY PHARMEDIUM, INC.| VERSED 2MG