BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2488369 · Received March 12, 2012

    Report

    Report Number
    1423500-2012-05980
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    February 29, 2012
    Report Date
    February 29, 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 EVENT WAS THE RESULT OF A USE ERROR; THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER. FOR THIS REASON, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR USE ERROR - REUSE OF SINGLE-USE PRODUCT DUE TO USE ERROR WAS CONFIRMED. THE CAUSE WAS UNDETERMINED. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR USE/USER ERROR RELATED TO THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK HEATER LINE (CHL) ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING FILL 1. THE HOME PATIENT (HP) STATED HE CHANGED OUT ONLY THE HEATER BAG AFTER THE FIRST ALARM AND RESUMED FILL 1. THE HC REALARMED AND THE TSR EXPLAINED THE SETUP WAS COMPROMISED. THE HP UNDERSTOOD AND THE TSR ADVISED THE HP TO START OVER WITH 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 ON (B)(4) 2012 AND HE WAS ABLE TO RESUME THERAPY AFTER STARTING OVER WITH NEW SUPPLIES. HE HAD TWO CHL ALARMS THAT DAY AND THE FIRST ONE HAD AN OCCLUDED FRANGIBLE AND THE SECOND CHL ALARM HE WAS NOT SURE WHAT WAS WRONG, JUST THAT SOLUTION WOULD NOT FLOW FROM THE HEATER BAG EVEN THOUGH THE FRANGIBLE WAS NOT OCCLUDED. HE DID NOT HAVE A SAMPLE OR A LOT NUMBER FOR EITHER CHL ALARM. HE HAD ALREADY GONE OVER THE CORRECT PROCEDURES FOR STARTING OVER WITH NEW SUPPLIES WITH THE TSR. 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOME CHOICE