BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMBRO CARTRIDGE BLOOD SET

    MDR report key: 1732329 · Received June 17, 2010

    Report

    Report Number
    8030638-2010-00005
    Event Type
    Injury
    Date Received
    June 17, 2010
    Date of Event
    May 19, 2010
    Report Date
    May 21, 2010
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLOOD TUBING SET INVOLVED IN THIS INCIDENT WAS RETAINED BY THE FACILITY AND WILL NOT BE RELEASED TO GAMBRO FOR INVESTIGATION. RETAINED BLOOD TUBING SAMPLES FROM THE SAME LOT NUMBER FROM WHICH THE INVOLVED BLOOD TUBING SET CAME (02R158204) WERE VISUALLY INSPECTED, FUNCTIONAL AND DIMENSIONAL TESTING PERFORMED WITH NO FAILURES DETECTED. GAMBRO HAS FOUND NO INFO TO SUGGEST THAT ANY GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENT.

    Description of Event or Problem · 1

    THIRTY FIVE MINS INTO A SCHEDULED THREE-HOUR TREATMENT, PT COMPLAINED OF CHEST PAIN, NAUSEA, AND SHORTNESS OF BREATH, SHE WAS PLACED ON A CARDIAC MONITOR, GIVEN PAIN ANTI-NAUSEA MEDICATIONS, AND HER SHORTNESS OF BREATH SUBSIDED. SHE CONTINUED TO RECEIVE 100% OXYGEN, VIA NASAL CANNULA, AT 3 LITERS PER MIN. THE BLOOD PUMP WAS STOPPED FOR ABOUT THREE MINS WHILE THE ARTERIAL NEEDLE WAS REPLACED. THE NURSE REPORTED THAT THE BLOOD IN THE EXTRACORPOREAL CIRCUIT WAS NOT RECIRCULATED WHILE THE BLOOD PUMP WAS STOPPED. ABOUT 1/2 HOUR LATER, THE PT COMPLAINED OF SEVERE ANTERIOR WALL CHEST PAIN AND SHE INSISTED THAT HER DIALYSIS TREATMENT BE TERMINATED. THE TREATMENT WAS TERMINATED EARLY AND THE BLOOD IN THE CIRCUIT WAS RETURNED TO THE PT. THE LAB REPORTED THAT THE BLOOD SAMPLE WAS HEMOLYZED. THE PT WAS TRANSFERRED TO THE ICU. SHE RECEIVED A TRANSFUSION OF ONE UNIT OF PACKAGED RED BLOOD CELLS. AN ECHOCARDIOGRAM WAS PERFORMED, AND IT REVEALED SOME APICAL AND DISTAL ANTERIOR WALL MOTION ABNORMALITIES WITH MILD REDUCTION IN EJECTION FRACTION, WITH SOME MILD LEAKY MITRAL VALVE AND MODERATE PULMONARY HYPERTENSION. THE CARDIOLOGIST'S IMPRESSION IS THAT THE PT SUFFERED A POSSIBLE THROMBOTIC EVENT; AN ACUTE MYOCARDIAL INFARCTION WITH NEW WALL MOTION ABNORMALITIES. ABOUT FOUR HOURS LATER, HEMODIALYSIS WAS ATTEMPTED, BUT UPON INITIATION OF TREATMENT THE MACHINE IMMEDIATELY GENERATED A BLOOD LEAK ALARM, PINK TINGED FLUID OBSERVED IN THE EFFLUENT DIALYSATE LINE AND AT THE DRAIN. A HEMASTICK WAS POSITIVE FOR THE PRESENCE OF BLOOD. THE PT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER CARE. AS OF 06/03/2010, SHE REMAINED HOSPITALIZED, BUT WAS TO BE DISCHARGED THAT DAY. NO KINKS WERE FOUND IN THE BLOOD TUBING SET. THE NURSE ALSO DID NOT OBSERVE THE LINES BOUNCING AND DID NOT HEAR ANY UNUSUAL NOISES COMING FROM THE BLOODLINES. THE HOSPITAL HAS RETAINED THE BLOOD TUBING SET AND WILL NOT BE RELEASED TO GAMBRO. A REVIEW OF THE GLOBAL CUSTOMER EVENT DATABASE FOR THE CARTRIDGE BTS LOT NUMBER, AND FOR THE BICART 720G LOT NUMBER REVEALS NO REPORTS OF ANY ADVERSE EVENTS. A GAMBRO TECHNICAL SPECIALIST INSPECTED THE CENTRYSYSTEM 3 MACHINE AND FOUND THE MACHINE WAS OPERATING WITHIN MANUFACTURER'S SPECIFICATIONS.

    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 02R158204

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R MEDYSYSTEM 15 GAUGE SHORT, LOT NUMBER UNKNOWN| MONITOR CENTRYSYSTEM 3. (B)(4), SW 15.5| BICART 720G, LOT# 05046| DIALYZER BAXTER EXELTRA 15, LOT# 09K05A| LOT NUMBER 10CXAC038| ACID CONCENTRATE FRESENIUS NATURALYTE 4010