BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABRATEK 6060 PUMP

    MDR report key: 317974 · Received February 26, 2001

    Report

    Report Number
    MW1021196
    Event Type
    Malfunction
    Date Received
    February 26, 2001
    Date of Event
    February 21, 2001
    Report Date
    February 26, 2001
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT CALLED - UNABLE TO GET PUMP TO WORK. DISPLAY READS MALFUNCTION-18. PHARMACY WILL DELIVER REPLACEMENT PUMP AND CHECK CURRENT PUMP FOR MALFUNCTION. UPON OBSERVATION IT WAS NOTED THAT TOTAL PARENTERAL NUTRITION SOLUTION HAD LEAKED INTO THE PERISTALTIC MOTOR UNIT. TUBING WAS PREVIOUSLY REMOVED AND DISCARDED SO IT WAS UNAVAILABLE FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7710 SABRATEK 6060 PUMP AMBULATORY INFUSION PUMP FRN BAXTER HEALTHCARE 6060 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other LOT# 001888.| 1) 560112-GEL TUBING FOR SABRATEK 6060 PUMP,