BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3070744 · Received April 22, 2013

    Report

    Report Number
    1416980-2013-09985
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 31, 2013
    Report Date
    March 31, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. PER BAXTER LABELING, USERS ARE INSTRUCTED TO PROPERLY CONNECT THE SOLUTION BAGS TO THE CASSETTE LINES WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING THE SUPPLY BAG BECOMING DISCONNECTED DURING DWELL WHILE THE HOME PATIENT (HP) WAS CONNECTED. THE TSR ADVISED THE CG TO DISPOSE OF CURRENT SUPPLIES ATTACHED AND START OVER WITH ALL NEW SUPPLIES. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. PRODUCT SURVEILLANCE CONTACTED THE CAREGIVER ON (B)(6) 2013 AND SHE SAID THAT SHE DID NOT NOTICE ANYTHING WRONG WITH THE SUPPLIES. SHE SAID THAT HER HUSBAND HAD THOUGHT HE HAD HOOKED UP THE BAG TO THE LINE CORRECTLY, BUT HE HAD NOT AND IT CAME UNDONE WHILE IN THERAPY. SHE DID NOT HEAR AN ALARM BUT SHE HEARD THE SOLUTION COMING OUT OF THE LINE AND BAG. SINCE THEN HE HAS BEEN COMPLETING THERAPY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172848 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR HOMECHOICE