BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAX BLOOD WARMER DISPOSABLE

    MDR report key: 17691138 · Received September 6, 2023

    Report

    Report Number
    1416980-2023-04499
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 9, 2023
    Report Date
    September 6, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    UDI-DI
    37332414123933
    PMA / PMN Number
    K190910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6). H4: DEVICE MANUFACTURE DATE: THE DEVICE WAS MANUFACTURED BETWEEN (B)(6) 2023 AND (B)(6) 2023. H10: THE DEVICE WAS RECEIVED FOR EVALUATION ATTACHED TO THE PRISMAFLEX HP-X SET. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. TRACES OF COAGULATED BLOOD WERE OBSERVED ON THE LUER CONNECTOR BETWEEN THE THERMAX AND RETURN LINE. THIS CONNECTION HAS BEEN ISOLATED FROM THE REST OF THE ASSEMBLY, WITHOUT MANIPULATING THE CONNECTION BETWEEN THE TWO DEVICES (CONNECTION MADE BY THE CUSTOMER) SO AS NOT TO ALTER IT. AN AIR LEAK TEST WAS PERFORMED (0.5BAR) AND A LEAK WAS OBSERVED AT THE LEVEL OF THE LUER CONNECTION. THE REPORTED CONDITION WAS VERIFIED. UPON DISCONNECTING THE THERMAX AND THE RETURN LINE, NO ANOMALY WAS NOTED AT THE CONNECTORS LUERS. THE CONNECTION BETWEEN THE PRISMAFLEX HP-X SET AND THE THERMAX WARMER BAG WAS RESTORED, AND AN AIR LEAK TEST WAS PERFORMED (0.5BAR). NO LEAK WAS OBSERVED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM A THERMAX BLOOD WARMER DISPOSABLE. THIRTY MINUTES INTO CONTINUOUS RENAL REPLACEMENT THERAPY THE LEAK WAS OBSERVED FROM THE LUER LOCK CONNECTION BETWEEN THE THERMAX DISPOSABLE AND THE RETURN BLOOD LINE OF THE PRISMAFLEX HP-X SET. TREATMENT WAS DISCONTINUED WITHOUT BLOOD RESTITUTION AND THE ACCUMULATED BLOOD LOSS WAS 192ML. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056254 THERMAX BLOOD WARMER DISPOSABLE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION NA 23C06 37332414123933

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PRISMAFLEX HP-X SET.| PRISMAX MACHINE.| THERMAX BLOOD WARMER.