BEUDAMED
    FDA Adverse Event Death Summary report: N

    THE MICRO TEMP

    MDR report key: 771237 · Received August 24, 2006

    Report

    Report Number
    MW4004225
    Event Type
    Death
    Date Received
    August 24, 2006
    Date of Event
    June 8, 2006
    Report Date
    August 24, 2006
    Manufacturer
    CINCINNATI SUB-ZERO
    Product Code
    DWJ
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT CALLED IN STATING THAT HER NEWBORN SON (BORN IN 2006), WHO WAS TRANSFERRED FROM ONE HOSP THE NIGHT OF HIS DELIVERY TO ANOTHER HOSPITAL, WAS PLACED ON THE EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO), A HEART/LUNG BYPASS MACHINE. ACCORDING TO THE COMPLAINANT, THE MACHINE HAD MALFUNCTIONED TWICE AND HER SON WAS LEFT ON THE MACHINE FOR APPROX 4 HOURS THEREAFTER. SHE STATED DURING THAT TIME SHE WAS UNSURE WHETHER HOSP PERSONNEL WERE TRYING TO GET ANOTHER HEAT EXCHANGER OR ANOTHER ECMO MACHINE. AS A RESULT OF THE MACHINE MALFUNCTIONING, COLD BLOOD WAS CIRCULATED THROUGHOUT HER SON'S BODY. HER SON PASSED AWAY 12 DAYS LATER. SHE CONTACTED THE MFR, CINCINNATTI SUB-ZERO, LOCATED IN CINCINNATTI, OHIO AND WAS TOLD BY THEM THAT THE HOSP WAS USING THE WRONG/OUTDATED EQUIPMENT AND THAT THE MICRO TEMP 1 (THAT WAS USED ALONG WITH THE ECMO MACHINE TO WARM THE BLOOD) IS NOT TO BE USED FOR WARMING THE WHOLE BODY. THE CONSUMER STATED SHE HAD CONTACTED AN FDA OFFICE BACK EAST, BUT WAS UNABLE TO PROVIDE ME WITH THE APPROPRIATE OFFICE OR THE NAMES OF INDIVIDUALS TO SPEAK TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE MICRO TEMP * DWJ CINCINNATI SUB-ZERO * *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DAY Death