BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2925690 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01651
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED DURING A SAMPLE EVALUATION AND THE ROOT CAUSE WAS DETERMINED TO BE A HOLE IN THE TUBING. A VISUAL INSPECTION WAS PERFORMED WITH A CUT ON THE TUBING ABOUT 58 INCHES AWAY FROM THE TUBING END NOTED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. A BATCH REVIEW COULD NOT BE CONFIRMED SINCE THE LOT NUMBER WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER (B)(4) REGARDING A LEAK FROM A CASSETTE. THE NURSE STATED THAT A LEAK WAS OBSERVED FROM THE CONNECTOR LINE DURING USE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29023 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1