BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMBRO CARTRIDGE BLOOD SET

    MDR report key: 2223521 · Received July 15, 2011

    Report

    Report Number
    8030638-2011-00017
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    GAMBRO RENAL PRODUCTS S.A. DE C.V.
    Product Code
    KOC
    PMA / PMN Number
    K070414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLOOD TUBING SET INVOLVED IN THIS INCIDENT WAS RETAINED BY THE CUSTOMER, AND WAS NOT AVAILABLE FOR INVESTIGATION. THE LOT NUMBERS OF RECENT CARTRIDGE BLOOD TUBING SETS SHIPPED TO THIS FACILITY WERE: 1000005288; 1000006264; 1000007918; 1000006661; 1000009512; 10000010001; 1000004397; 1000005287 AND 1000009501. ONE HUNDRED AND THIRTY FIVE RETAINED SAMPLES FROM THE 9 LOT NUMBERS LISTED ABOVE WERE TESTED BY MEANS OF FUNCTIONAL, LEAK AND STRESS TESTS AND VISUAL INSPECTION. THE TESTS IDENTIFIED NO PROBLEMS WITH ANY OF THE SAMPLES AND CONFIRMED THAT THEY MET THE PRODUCT SPECS. REVIEW OF THE COMPLAINT DATABASE REVEALED THERE WERE NO OTHER SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    THREE HOURS AND 40 MINUTES INTO TREATMENT THE CARTRIDGE BLOOD TUBING REPORTEDLY FRACTURED AT THE CONNECTING HUB OF THE VENOUS RETURN LINE, RESULTING IN A BLOOD LOSS OF APPROX 300 ML. TREATMENT WAS ENDED; THERE WAS NO BLOOD TRANSFUSION OR MEDICAL INTERVENTION AND THE PT WAS DISCHARGED HOME IN STABLE CONDITION. THE CARTRIDGE BLOOD SET IS BEING RETAINED BY THE FACILITY'S RISK MGMT AND WILL NOT BE RETURNED TO GAMBRO. THE PHOENIX MACHINE WAS NOT INSPECTED. FACILITY RISK MGMT DEEMED THE PHOENIX MACHINE FUNCTIONED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO CARTRIDGE BLOOD SET BLOOD TUBING SET KOC GAMBRO RENAL PRODUCTS S.A. DE C.V. 101025 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR BLOOD TUBING SET (LOT # UNK)| BICART (LOT # UNK)| PHOENIX MACHINE (LOT # UNK)