BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 2090398 · Received May 16, 2011

    Report

    Report Number
    1423500-2011-06032
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB FOR A DAMAGED SET. ROOT CAUSE WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CAREGIVER (CG) CONTACTED PRODUCT SURVEILLANCE ON (B)(6) 2011 REGARDING FINDING (B)(4) DAMAGED CASSETTES. THE CG STATED THAT HE FOUND A HAIR LINE FRACTURE IN THE UPPER LEFT BLADDER PORTION ON THE CASSETTES. THE CG REPORTED THAT HE FOUND THIS BEFORE USE, DURING SET UP. THE CG SAID THAT SOME OF THE CASSETTES HE COULD IDENTIFY THE LOT NUMBERS (H11A05012 AND H10J05031) AND SOME HE COULD NOT BECAUSE THEY WERE OPEN AND HE HAD DISCARDED THE WRAPPER. THE CG DID NOT USE THE CASSETTES AND WILL HOLD ALL THEM FOR EVALUATION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 41 OF 54. PRODUCT SURVEILLANCE CONTACTED HOMECARE SERVICES (HCS) ON (B)(6) 2011 REGARDING THE CAREGIVER (CG) FINDING A NUMEROUS CASSETTES WITH A HAIR LINE FRACTURE. HCS SAID THEY HAVE SPOKEN WITH THE CG AND THAT THEY ARE SHIPPING THE CG SOME EMERGENCY SUPPLIES SINCE THE CG WENT THROUGH 2 BOXES OF CASSETTES. HCS IS ALSO ISSUING THE CG A CREDIT FOR THE DAMAGED CASSETTES. PRODUCT SURVEILLANCE WAS CONTACTED BY THE HOME PATIENT'S REGISTERED NURSE (RN) ON (B)(6) 2011 REGARDING THE DAMAGED CASSETTES. THE NURSE STATED THAT SHE HEARD FROM THE CAREGIVER (CG) ABOUT THE DAMAGED CASSETTES AND HAD THE CG BRING A SAMPLE OF THE CASSETTES TO THE CLINIC TO COMPARE WITH THE CLINIC'S CASSETTES. THE RN STATED THAT SHE SAW THE MARK THAT THE CG HAD REFERRED TO AS A "HAIR LINE FRACTURE" AND FELT THAT IT WAS NOT A "HAIR LINE FRACTURE", BUT A MARK LEFT FROM MANUFACTURING. THE RN STATED THAT HER CASSETTES HAD A SIMILAR MARKING AND THEY HAVE BEEN USING THEM WITH NO ISSUES. THE RN WAS UNSURE IF THE CG WOULD USE THE CASSETTES NOW OR SEND THEM ALL BACK FOR EVALUATION. NO FURTHER INFORMATION AVAILABLE. PRODUCT SURVEILLANCE CONTACTED THE CAREGIVER (CG) ON (B)(6) 2011 REGARDING RETURNING CASSETTES FOR EVALUATION. THE CG STATED THAT THEY PLAN ON RETURNING THE CASSETTES FOR EVALUATION, BUT THEY HAVE BEEN VERY BUSY WITH THE HOME PATIENT'S APPOINTMENTS. THE CG SAID THAT HE WILL TRY TO RETURN. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO