BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMAFLO II

    MDR report key: 2877665 · Received December 13, 2012

    Report

    Report Number
    9616026-2012-00007
    Event Type
    Other
    Date Received
    December 13, 2012
    Date of Event
    November 10, 2012
    Report Date
    November 13, 2012
    Manufacturer
    STIHLER ELECTRONIC GMBH
    Product Code
    KOC
    PMA / PMN Number
    K082758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SERIAL NUMBER: HEATING UNIT SN: (B)(4). THE TECHNICAL INVESTIGATION IS STILL IN PROGRESS BY (B)(4) WHO IS THE MFR OF THE PRISMAFLO II BLOOD WARMER. THE HEATING PROFILE SLEEVE WAS PLACED UNDER A PILLOW IN THIS EVENT. THIS IS NOT ACCORDING TO THE INSTRUCTIONS FOR USE (OPERATOR'S MANUAL) WHICH STATES: THE HEATING PROFILE MAY NOT BE COVERED DURING USE. THE PRISMAFLO ISSUED A MALFUNCTION ALARM IN THE REPORTED EVENT (HIGH TEMP). FOR EVERY MALFUNCTION RELATED ALARM ISSUED, THE PRISMAFLO BLOOD WARMER ENTERS A SAFE STATE BY SWITCHING OFF THE HEAT SUPPLY (ELECTRICAL CURRENT) AUTOMATICALLY.

    Description of Event or Problem · 1

    GAMBRO RECEIVED A REPORT THAT A HEATING PROFILE SLEEVE OF A PRISMAFLO II BLOOD WARMER OVER HEATED AND BURNED A PILLOW DURING CVVH TREATMENT. DURING THE DIALYSIS TREATMENT, THE BEDSIDE NURSE REPORTED SMELLING "A BURNING ODOR" BUT COULD NOT IDENTIFY THE SOURCE. THE PRISMAFLO II ISSUED AN ALARM FOR HIGH TEMP AND THE NURSE TRACED THE RETURN LINE HEATING PROFILE SLEEVE, WHICH HAD BEEN PLACED UNDERNEATH A PILLOW. BURN MARKS WAS FOUND ON THE PILLOW. THE PT EXPERIENCED NO SYMPTOMS AND HAD NO CHANGE IN VITAL SIGNS. THERE WAS NO ADVERSE EVENT TO THE PT AND NO MEDICAL INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLO II BLOOD WARMER KOC STIHLER ELECTRONIC GMBH 113281

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other M100 FILTER SET: LOT # NOT PROVIDED| PRISMAFLEX CONTROL UNIT: SN NOT PROVIDED