BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP BODYGUARD AMBULATORY

    MDR report key: 8206424 · Received December 28, 2018

    Report

    Report Number
    MW5082698
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Report Date
    December 10, 2018
    Manufacturer
    CME AMERICA, LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CLIENT'S NURSE REPORTS THAT THE PUMP WAS HAVING SOME ISSUES, BUT WAS ABLE TO INFUSE THE FULL DOSE AND NO SIDE EFFECTS WERE REPORTED. NURSE REPORTED THAT PUMP KEPT BEEPING AND WOULD STOP WORKING. SHE HAD TO CHANGE THE TUBING 4 TIMES. NO OTHER DETAILS GIVEN. PATIENT STILL HAS PUMP BUT A REPLACEMENT PUMP WILL BE SENT TO CLIENT. REPORTED TO (B)(6) BY: HEALTH PROFESSIONAL. DOSE OR AMOUNT :N/A; FREQUENCY: Q 2 WEEKS; ROUTE: IV; DATES OF USE: FROM (B)(6) 2018 TO CURRENT; DIAGNOSIS OR REASON FOR USE: POMPE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044081 PUMP BODYGUARD AMBULATORY PUMP, INFUSION FRN CME AMERICA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1