BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3083620 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10742
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS NOT AVAILABLE AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. PER BAXTER LABELING, USERS ARE INSTRUCTED THAT DISPOSABLE PRODUCTS ARE INTENDED FOR SINGLE USE ONLY WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING AN UNRELATED ALARM THAT OCCURRED DURING USE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HOME PATIENT (HP) TO END THE THERAPY AND START OVER USING ALL NEW SUPPLIES. THE TSR ASSISTED THE HP TO REMOVE THE CASSETTE. THE TSR ADVISED THE HP TO DISPOSE OF ALL CURRENT SUPPLIES USED. THE HP STATED THEY MAY NOT DO THAT, THEY MAY REUSE THE SAMPLE SUPPLIES. THE HOMECHOICE (HC) WAS OPERATIONAL AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) REGARDING WHETHER OR NOT THEY REUSED THE SUPPLIES. THE HP STATED SHE REUSED THE SUPPLIES FROM THAT NIGHT BECAUSE SHE WAS EXTRA CAREFUL. THE HP STATED SHE IS A NURSE AND KNOWS WHEN IT'S OKAY TO USE THE SUPPLIES OR NOT RE-USE THE SUPPLIES. PRODUCT SURVEILLANCE INFORMED THE HP THAT ANYTIME A TECHNICAL SERVICE REPRESENTATIVE (TSR) FROM BAXTER RECOMMENDS STARTING OVER WITH NEW SUPPLIES, THERE IS SOME RISK OF CONTAMINATION OR INTRODUCTION OF FOREIGN MATERIAL TO THE HP. THE TSR HAS THE HP START OVER WITH NEW SUPPLIES AS A WAY TO PREVENT INFECTION. THE HP STATED SHE DID NOT THINK THEY NEEDED TO EVEN IF THE TSR RECOMMENDED IT. PRODUCT SURVEILLANCE INFORMED THE HP THEY COULD ALWAYS PERFORM MANUAL THERAPY IF THEY DID NOT WISH TO SETUP WITH NEW SUPPLIES. THE HP INDICATED THEY WOULD NEVER USE MANUAL THERAPY. THE HP INDICATED THEY DO NOT RE-USE THE SUPPLIES AFTER PERFORMING A FULL THERAPY, JUST IN CASES WHERE THEY BELIEVE THEY DO NOT HAVE TO START OVER PARTIALLY THROUGH THE THERAPY. NO ADDITIONAL INFORMATION WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185081 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOMECHOICE