BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3002865 · Received March 13, 2013

    Report

    Report Number
    1416980-2013-06064
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP INFORMATION WAS RECEIVED FROM THE HOME PATIENT (HP), REGARDING THE LEAK IN THE PATIENT LINE. THE HP STATED THAT THE TUBING HAD NOT BEEN FULLY CONNECTED TO THE PATIENT LINE CONNECTOR, WHICH THEN HAD LEAKED. THIS OCCURRED DURING PRIME, WHEN THE HP WAS NOT CONNECTED. THE HP STARTED OVER WITH NEW SUPPLIES. THE HP STATED THAT THE LINE WAS AVAILABLE AND WOULD RETURN THE SAMPLE FOR EVALUATION. THE HP STATED THAT OTHER CASSETTES, OF THE SAME LOT, HAVE BEEN FOUND TO HAVE THE SAME ISSUE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). AT THIS TIME, THE SAMPLE IS NOT AVAILABLE FOR ANALYSIS. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT OBSERVED A LEAK IN AN AUTOMATED PD CASSETTE FROM A TUBE THAT CAME LOOSE DURING PERITONEAL DIALYSIS (PD) THERAPY. THE ISSUE CAUSED PD SOLUTION TO LEAK OUT DURING USE, WHILE THE PATIENT WAS LYING DOWN. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105960 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H12I14016

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE