BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMA M100 SET

    MDR report key: 3813581 · Received May 15, 2014

    Report

    Report Number
    8010182-2014-00022
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 5, 2014
    Report Date
    May 15, 2014
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    PMA / PMN Number
    K032431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014 AT 0843 MDT, GAMBRO RECEIVED EMAIL NOTIFICATION FROM ESG HELP DESK THAT THE FDA GATEWAY WAS UNAVAILABLE. ON (B)(4) 2014 AT 0300 EDT, ESG HELP DESK SENT OUT THE NOTICE THAT THE FDA GATEWAY WAS NOW AVAILABLE FOR PRODUCTION. AS A RESULT, THIS EMDR WAS NOT SUBMITTED UNTIL (B)(4) 2014. THE PRISMA M100 PRE SET WAS DISCARDED AND NOT AVAILABLE FOR INSPECTION. PICTURES OF THE INVOLVED LINE WERE PROVIDED. A CRACK WAS DETECTED ON THE RETURN LINE. THIS CRACK COULD BE THE ROOT CAUSE OF THE REPORTED EXTERNAL BLOOD LEAKAGE, HOWEVER, NO LEAKAGE WAS REPORTED DURING THE PRIMING OF THE PRISMA M100 SET. THE ROOT CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN. THE REVIEW OF THE PRISMA M100 PRE SET DEVICE HISTORY RECORD FOR LOT NUMBER 13F0303 SHOWS THAT NO MANUFACTURING ANOMALY WAS RECORDED REGARDING THIS LOT NUMBER. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    A CRITICALLY ILL PATIENT IN CHINA WAS UNDERGOING CONTINUOUS RENAL REPLACEMENT THERAPY ON A PRISMA MACHINE WITH A PRISMA M100 FILTER. FOLLOWING THE INITIATION OF TREATMENT, THE NURSE OBSERVED AN BLOOD LEAK ON THE VENOUS RETURN LINE. TREATMENT WAS STOPPED AND THE BLOOD IN THE EXTRACORPOREAL CIRCUIT WAS NOT RETURNED TO THE PATIENT RESULTING IN AN ESTIMATED BLOOD LOSS OF 107 ML. THE PATIENT WAS NOT SYMPTOMATIC AND DID NOT REQUIRE ANY MEDICAL INTERVENTION AS A RESULT OF THE BLOOD LOSS. TREATMENT WAS RESTARTED WITH A NEW FILTER SET WITHOUT ANY REPORTED COMPLICATIONS. GAMBRO LATER LEARNED THE PATIENT EXPIRED THE FOLLOWING DAY. THE CAUSE OF DEATH WAS REPORTED AS HEART FAILURE. FURTHER PATIENT AND TREATMENT RELATED DATA WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290280 PRISMA M100 SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO INDUSTRIES 103657 13F0303

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other PRISMA (SN UNKNOWN)