BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONATE PACK

    MDR report key: 4093098 · Received August 21, 2014

    Report

    Report Number
    2248146-2014-00381
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE RETURNED COMPONENTS CONFIRMED THE REPORTED LEAK IN THE PRIMING BAG. THE MANUFACTURING SITE FOR THIS COMPONENT HAS BEEN NOTIFIED OF THIS ISSUE AND AN INVESTIGATION IS BEING CONDUCTED TO PREVENT FUTURE OCCURRENCES. (B)(4).

    Description of Event or Problem · 1

    NO PT INJURY OR REQUIRED INTERVENTION. LAST NIGHT A CHILD WAS SETUP ON ECMO. THE PRIMING BAG IN THE ROLLER HEAD CIRCUIT WAS LEAKING AROUND THE AREA WHERE THE OUTFLOW LINE CONNECTS TO THE BAG. THE HOSP THOUGHT THIS WAS A ONE TIME OCCURRENCE BUT IT HAS HAPPENED 3 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506901 NEONATE PACK CARDIOPULMONARY DEVICE DSP DATASCOPE CORP BEQ-TOP 28601

    Patients

    Seq Age Sex Outcome Treatment
    1