BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2850074 · Received November 29, 2012

    Report

    Report Number
    1416980-2012-06099
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE PROBLEM WAS CONFIRMED. THE ROOT CAUSE WAS ANIMAL DAMAGE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A SAMPLE EVALUATION WILL NOT BE CONDUCTED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE NO BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THERAPY ASSISTANCE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DWELL 1. THE HOME PATIENT'S (HP) CAT CHEWED THROUGH THE PATIENT LINE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THEM TO CALL THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) IMMEDIATELY TO ADVISE THEM OF THE CIRCUMSTANCES. THE TSR HAD DETERMINED THE HP HAD ALREADY DISCONNECTED. THE TSR ASSISTED THE CAREGIVER (CG) WITH ENDING THERAPY AND REMOVING THE CASSETTE. THE TSR ADVISED THE CG TO DISPOSE OF THE CURRENT SUPPLIES ATTACHED AND START OVER WITH ALL NEW SUPPLIES. THE HC WAS OPERATIONAL. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S CAREGIVER ON (B)(4) 2012 AND SHE SAID THAT THEY ARE MORE CAREFUL NOW WITH THE CAT AND KEEPING IT OUT OF THE ROOM WHERE THE PATIENT DOES THERAPY. SHE CONTACTED HIS NURSE AND HE WAS GIVEN MORE ANTIBIOTICS AS A PRECAUTIONARY MEASURE. NO FURTHER INFORMATION WAS PROVIDED. 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
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR HOME CHOICE