BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMBRO CARTRIDGE BLOOD SET

    MDR report key: 2163435 · Received June 24, 2011

    Report

    Report Number
    8030638-2011-00015
    Event Type
    Injury
    Date Received
    June 24, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 26, 2011
    Manufacturer
    GAMBRO RENAL PRODUCTS S.A. DE C.V.
    Product Code
    FJK
    PMA / PMN Number
    K070414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLOOD TUBING SET INVOLVED IN THIS INCIDENT WAS DISCARDED AND, THEREFORE, WAS NOT AVAILABLE FOR INVESTIGATION. THE LOT NUMBER OF THE BLOOD TUBING SET WAS ALSO NOT AVAILABLE AND NO COMPANION SAMPLES WERE RETURNED. (B)(4). THERE WERE NO FAILURES OR DEFECTS FOUND IN ANY OF THE SAMPLES TESTED.

    Description of Event or Problem · 1

    EIGHTEEN MINUTES FOLLOWING THE INITIATION OF THE HEMODIALYSIS TREATMENT, MACHINE GENERATED THE "BLOOD LEAK DETECTED" ALARM. THERE WERE NO VISIBLE SIGNS OF A BLOOD LEAK BUT THE FLUID AT THE DRAIN TESTED POSITIVE FOR BLOOD. THE TREATMENT WAS DISCONTINUED AND THE PATIENT DISCHARGED HOME. FOLLOWING DISCHARGE FROM THE CLINIC, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR COMPLAINTS OF A RASH, HEMATOMA AT THE SITE OF HIS LEFT A/V FISTULA, DIFFICULTY SWALLOWING, AND THROAT DISCOMFORT. THE MEDICAL IMPRESSION ON ADMISSION WAS AS FOLLOWS: "MOST LIKELY ALLERGIC REACTION DURING HD AND RULE-OUT ACUTE CORONARY SYNDROME." THE PATIENT'S BLOOD WORK REVEALED AN ELEVATED LDH AND D DIMER WITH DECREASED HAPTOGLOBIN. THERE WAS NO OBVIOUS SCHISTOCYTES OR SPHEROCYTES TO SUGGEST ACTIVE HEMOLYSIS AND IT WAS DIFFICULT TO ESTABLISH A DEFINITIVE DIAGNOSIS, HOWEVER, THE TREATING PHYSICIAN BELIEVED THE PATIENT HAD EXPERIENCED SOME ELEMENT OF HEMOLYSIS. THE CARTRIDGE BLOOD SET, BICART AND REVACLEAR MAX DIALYZER WERE ALL DISCARDED. THE PHOENIX MACHINE WAS INSPECTED BY THE HOSPITAL BIOMED TECHNICIAN AND A GAMBRO SERVICE TECHNICIAN AND BOTH FOUND THE MACHINE TO BE OPERATING WITHIN MANUFACTURER'S SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization PHOENIX MACHINE: SN UNKNOWN| BICART: LOT # UNKNOWN| REVACLEAR MAX: LOT # C411200201