BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX M150

    MDR report key: 3781803 · Received April 30, 2014

    Report

    Report Number
    8010182-2014-00021
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 30, 2014
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    PMA / PMN Number
    K080519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE PRISMAFLEX M150 SET DEVICE HISTORY RECORD FOR LOT NUMBER 14A2107G SHOWS THAT NO MANUFACTURING ANOMALY WAS RECORDED REGARDING THIS LOT NUMBER. THE COMPLAINT HISTORY FILES SHOW NO SIMILAR COMPLAINT FOR LOT NUMBER 14A2107G. THE PRISMAFLEX M150 SET WAS RETURNED FOR INVESTIGATION. A CRACK WAS OBSERVED ON THE VENOUS DIALYZER LINE. IT IS UNLIKELY THAT THIS DEFECT OCCURRED DURING OUR MANUFACTURING PROCESS SINCE IT WOULD HAVE BEEN DETECTED DURING OUR IN-PROCESS CONTROL TEST. THE POTENTIAL ROOT CAUSES REGARDING THIS EVENT COULD BE : WEAKNESS OF THE VENOUS DIALYZER LINE; TOO MUCH CONSTRAINTS APPLIED ON THE VENOUS DIALYZER LINE BEFORE OR DURING TREATMENT. THE EXACT ROOT CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN AND WE HAVE NO INDICATION OF A GENERAL FAILURE ON THIS LOT NUMBER.

    Description of Event or Problem · 1

    DURING CRRT, THE NURSE OBSERVED AN EXTERNAL BLOOD LEAK ON THE FILTER SET. TREATMENT WAS STOPPED AND THE BLOOD FROM THE EXTRACORPOREAL CIRCUIT WAS NOT RETURNED TO THE PATIENT RESULTING IN AN ESTIMATED BLOOD LOSS OF 219 ML. THE PATIENT WAS NOT SYMPTOMATIC AND DID NOT REQUIRE ANY MEDICAL INTERVENTION AS A RESULT OF THE BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260332 PRISMAFLEX M150 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO INDUSTRIES 109990 14A2107G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PRISMAFLEX (SN : UNKNOWN)