BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVACLEAR DIALYZER

    MDR report key: 3023764 · Received March 27, 2013

    Report

    Report Number
    3023764
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 22, 2013
    Manufacturer
    GAMBRO RENAL PRODUCTS, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EMERGENT HEMODIALYSIS ORDERED FOR HYPERKALEMIA. PLACED ON CIRCULATION (1ST ATTEMPT) WITH REVACLEAR DIALYZER (LOT# C412122001): BLOOD LEAK ALARM AFTER BLOOD PUMP SPEED INCREASED AND DIALYZER FLIPPED. POSITIVE TEST FOR BLOOD (SERIM GUARDIAN BLOOD LEAK TEST STRIPS) AT DRAIN LINE AND OUTFLOW HANSEN CONNECTOR. BLOOD IN EXTRACORPOREAL CIRCUIT WASTED. PLACED ON CIRCULATION (2ND ATTEMPT) WITH REVACLEAR DIALYZER (LOT# C413103001): BLOOD LEAK ALARM AFTER BLOOD PUMP SPEED INCREASED AND DIALYZER FLIPPED. POSITIVE TEST FOR BLOOD (SERIM GUARDIAN BLOOD LEAK TEST STRIPS) AT DRAIN LINE AND OUTFLOW HANSEN CONNECTOR. BLOOD IN EXTRACORPOREAL CIRCUIT WASTED. PLACED ON CIRCULATION (3RD ATTEMPT) WITH REVACLEAR MAX DIALYZER (LOT# C412207201); BLOOD LEAK ALARM AFTER BLOOD PUMP SPEED INCREASED AND DIALYZER FLIPPED. POSITIVE TEST FOR BLOOD (SERIM GUARDIAN BLOOD LEAK TEST STRIPS) AT OUTFLOW HANSEN CONNECTOR (TEST FOR BLOOD ALSO REPLICATED AT OUTFLOW HANSEN CONNECTOR WITH SERIM GUARDIAN BLOOD LEAK TEST STRIPS FROM DIFFERENT CONTAINER). BLOOD IN EXTRACORPOREAL CIRCUIT WASTED. PLACED ON CIRCULATION (4TH ATTEMPT) WITH BAXTER DIALYZER: HEMODIALYSIS SUCCESSFULLY INITIATED. BLOOD LOSS APPROX 250 ML FOR EACH FAILED TREATMENT (TOTAL 750 ML). PT EXPERIENCED CARDIAC ARREST (PEA) APPROX 1 HOUR AFTER TREATMENT INITIATED. LAB WORK DURING CODE BLUE INCLUDED I-STATE K 4.6 AND H/H 5.6 / 17.7 (HGB 12.5 AT 1945 PRIOR TO HEMODIALYSIS). NO OBVIOUS SOURCES OF BLEEDING IDENTIFIED. PT RESUSCITATED AND TRANSFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126132 REVACLEAR DIALYZER SINGLE USE HIGH FLOW DIALYZER KDI GAMBRO RENAL PRODUCTS, INC. C412122001
    126133 REVACLEAR DIALYZER SINGLE USE HIGH GLOW DIALYZER KDI GAMBRO RENAL PRODUCTS, INC. C413103001
    126134 REVACLEAR DIALYZER SINGLE USE HIGH FLOW DIALYZER KDI GAMBRO RENAL PRODUCTS, INC. C412207201

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening