BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATROL PUMP

    MDR report key: 1924293 · Received December 7, 2010

    Report

    Report Number
    1527460-2010-00197
    Event Type
    Death
    Date Received
    December 7, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    K943733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    DIETICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEATH. THE FACILITY DID NOT DOCUMENT THE PUMP SERIAL NUMBER USED WITH THE PATIENT. THE REPORTER IS NOT ABLE TO DETERMINE THE PUMP USED WITH THE PATIENT, AS THE PUMP WAS REMOVED FROM THE PATIENT'S ROOM AND SENT TO A CLEAN ROOM WITH OTHER PUMPS. (B)(4)

    Description of Event or Problem · 1

    A NURSE INFUSED A BOLUS FEEDING OF 250CC AT AN INFUSION RATE OF 250CC PER HOUR AND INFUSED THE ENTIRE 1000CC INTO THE PATIENT. AS A RESULT, THE PATIENT BECAME CRITICAL, WAS TRANSFERRED TO ICU, AND LATER DIED. SHE HAD A MYOCARDIAL INFARCTION. PER THE REPORTER, THERE WAS NO RELATIONSHIP OF THE DEATH TO THE DEVICE. IN SUMMARY, A NURSE INFUSED 1000 CC OF FEED OVER 1-3 HOURS TO A PATIENT WHO WAS INTENDED TO RECEIVE 250 CC OF FEED. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 12, 2010, INDICATED THE PATIENT VOMITED AND HAD SHORTNESS OF BREATH AFTER RECEIVING FEEDING. PATIENT EXPERIENCED O2 SATURATION AND WAS PLACED ON A BIPAP MACHINE AND WAS TRANSFERRED TO THE ICU. THE PATIENT RESUMED TUBE FEEDING THE NEXT DAY AND TOLERATED IT WELL. THE PATIENT EXPIRED THREE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATROL PUMP LZH, PUMP, INFUSION, EXTERNAL LZH ABBOTT NUTRITION 52036

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death