BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABRATEK 6060 HOMERUN PUMP

    MDR report key: 808635 · Received November 22, 2004

    Report

    Report Number
    6000001-2004-01863
    Event Type
    Malfunction
    Date Received
    November 22, 2004
    Date of Event
    November 3, 2004
    Report Date
    November 17, 2004
    Manufacturer
    BAXTER/SABRATEK CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN RECEIVED AND A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION.

    Description of Event or Problem · 1

    PHARMACY REPORTED AN OVER INFUSION OF VANCOMYCIN USING A 6060 SABRATEK PUMP AND 2M9859 PUMP SET. DOSE WAS 1 GM Q 12 HRS WITH 89 ML PER DOSE. TOTAL DRUG WAS 6 GRAMS OVER 3 DAYS. TOTAL VOLUME WAS DELIVERED OVER 8 HRS. FIFTEEN - (15) HRS POST EVENT PTS BLOOD LEVEL WAS 18.7. RANGE SHOULD BE 5.0 TO 15.0. NO MEDICAL INTERACTION AND NO ADVERSE AFFECTS WERE REPORTED. PHARMACY STATED PTS NEXT DOSE OF VANCOMYCIN WOULD BE HELD TILL BLOOD LEVEL DECREASES. PHARMACY REPORTED ADMINISTRATION SET NOT AVAILABLE. WRITER REQUESTED PUMP TO BE RETURNED TO ROUND LAKE PAL FOR EVALUATION AND DATA LOG REVIEW. PT HAD REPORTED SEVERAL DOWN OCCLUSION ALARMS. PHARMACY REPORTED PUMP HAD BEEN RETURNED TO THEM ON 01/OCT/04 FOLLOWING SERVICE AND WAS SENT OUT TO PT IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABRATEK 6060 HOMERUN PUMP SABRATEK 6060 PUMP FRN BAXTER/SABRATEK CORP. 2M9832 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR