BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 1934193 · Received December 8, 2010

    Report

    Report Number
    1641965-2010-00112
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MFR FOR EVAL. THE MFR IS WORKING WITH THE FACILITY TO INVESTIGATE THE INCIDENT. ADD'L INFO WILL BE SENT VIA A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    REPORTED UNDER-INFUSION. PT WAS A PREEMIE NEWBORN. PUMP SET TO INFUSE 0.5CC OF INOCIN OVER 30 MINUTES. PUMP ALARMED "VOLUME TO BE INFUSED". NURSE OPENED THE COVER AND SAW THAT SOME OF THE DRUG STILL REMAINED IN THE SYRINGE. NURSE PUSHED "START" AGAIN. PUMP STARTED PRE-ALARMING "SYRINGE ALMOST EMPTY" THEN INFUSED THE REMAINING QUANTITY OF THE DRUG. USED A MONOJET 3CC SYRINGE (B)(4). NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFUSOR SPACE INFUSION PUMP FRN B. BRAUN MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1