BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1935926 · Received December 22, 2010

    Report

    Report Number
    1423500-2010-07150
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A CHECK HEATER LINE ALARM. THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. A BATCH REVIEW WAS NOT PERFORMED BECAUSE LOT INFORMATION WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE ALARM WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED. THE PRODUCT CODE IS UNKNOWN; THEREFORE THE 510K NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED THROUGH THE (B)(4) THROUGH BAXTER'S AFTERHOURS CALL SERVICE. A HOME PATIENT (HP) REPORTED THAT WHILE ON THE HOMECHOICE MACHINE, IT SOUNDED A CHECK HEATER LINE ALARM DURING FILL 1 OF 1. THE (HP) STATED THAT SHE SEES AIR IN THE PATIENT LINE. SHE WAS ADVISED TO END THE THERAPY AND START OVER WITH NEW SUPPLIES. NO SAMPLE IS AVAILABLE FOR EVALUATION. NO CLINICAL CONSEQUENCES FOR THE PATIENT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1