BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADD PCA AMBULATORY INFUSION PUMP

    MDR report key: 28196 · Received October 6, 1995

    Report

    Report Number
    28196
    Event Type
    Death
    Date Received
    October 6, 1995
    Date of Event
    August 3, 1995
    Report Date
    October 4, 1995
    Manufacturer
    PHARMACIA DELTEC, INC.
    Product Code
    MEA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POST-SURGICAL PT FOUND IN FULL ARREST. UNSUCCESSFUL RESUSCITATION. IN THE COURSE OF REVIEW OF CASE, IDENTIFIED AN UNEXPLAINED DISCREPANCY BETWEEN PUMP READINGS BEFORE ARREST AND READINGS. WHEN PUMP WAS INSPECTED LATER BY HOSP BIO-MED AND HOSP SUPPLY, CLINICAL PICTURE SUSPICIOUS FOR NARCOTIC BOLUS FREE-FLOW, AS MOST LIKELY EXPLANATION. LAST CHARTED PUMP READINGS 8/3/95 0400. RESERVOIR VOLUME: 38, TOTAL DOSES: 12. PUMP READINGS ON INSPECTION: RESERVOIR VOLUME: 20, TOTAL DOSES: 41.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD PCA AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP MEA PHARMACIA DELTEC, INC. 5800R

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death