BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 536203 · Received July 23, 2004

    Report

    Report Number
    2921482-2004-00431
    Event Type
    Death
    Date Received
    July 23, 2004
    Date of Event
    June 22, 2004
    Report Date
    June 28, 2004
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT HAD A RESPIRATORY ARREST WHILE ON A DEMEROL PCA PUMP WHICH WAS BOTH DEMAND AND BASAL RATE. THIRTY MINUTES PRIOR TO THE ARREST, THE PT WAS ALERT & ORIENTED DRINKING ORAL CONTRAST FOR A CT SCAN. PT WAS DIFFICULT TO RESUSCITATE WHICH A CARDIAC RHYTHM OF PULSELESS ELECTRICAL ACTIVITY. THE PT RECEIVED A TOTAL OF 110MG ACCORDING TO THE PUMP FROM 0500 UNTIL AN ARREST. PT WAS ALERT & ORIENTED DURING THAT TIME. IT IS HIGHLY UNLIKELY THAT THE PUMP CONTRIBUTED TO THE ARREST, BUT IT WAS RUNNING AT THE TIME OF THE ARREST. UPON FURTHER QUERY, THE FOLLOWING INFO WAS PROVIDED: THE PCA WAS POWERED IN 2004 AT 0500 FOR ABDOMINAL PAIN. THE PUMP WAS PROGRAMMED TO DELIVER DEMEROL 10 MG/ML IN THE PCA+CONTINUOUS MODE, A CONTINUOUS RATE OF 10 MG/ML, A 10MG BOLUS DOSE, A 6 MINUTE PT LOCKOUT, A 100MG 4HR LIMIT & A CONTAINER SIZE OF 300MG, REPORTEDLY, IN 2004 AT 1455, THE PT WENT INTO RESPIRATORY ARREST & A CODE WAS IMMEDIATELY CALLED. THE PT WAS INTUBATED & FOUND TO BE IN PEA (PULSELESS ELECTRICAL ACTIVITY) FOR APPROX 1HR BEFORE A HEAR RATE RETURNED." BLOOD WORK DRAWN DURING THE CODE INDICATED THE PT WAS IN "SEVERE METABOLIC ACIDOSIS & THE BRAIN NATRIURETIC PEPTIDE (BNP) WAS ELEVATED". THIRTY MINUTES PRIOR TO THE ARREST, THE PT WAS REPORTEDLY, "ALERT, ORIENTED & DRINKING THEIR CONTRAST MEDIA FOR AN UNSPECIFIED CT SCAN.". THE NEXT DAY REPORTEDLY, "THE PT WAS TAKEN OFF LIFE SUPPORT & EXPIRED". THE FAMILY ARRANGED FOR A PRIVATE AUTOPSY. THE CUSTOMER STATED, "CO DID NOT THINK THE PUMP HAD ANYTHING TO DO WITH THE PT'S DEATH." THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INFUSION PUMP FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R DEMEROL, MFR UNK.