BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2021126 · Received March 16, 2011

    Report

    Report Number
    1423500-2011-03183
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 20, 2011
    Report Date
    February 20, 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). THIS MDR WAS SUBMITTED ON (B)(6) 2011; HOWEVER, DUE TO A FAILURE TO RECEIVE THE 3 ACKNOWLEDGEMENTS, THIS MDR IS BEING RESUBMITTED ON (B)(6) 2011. PER THE CUSTOMER THE SAMPLE WAS DISCARDED, THEREFORE NO EVALUATION COULD BE PERFORMED. HOWEVER, A COMPANION SAMPLE WAS AVAILABLE AND HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE COMPANION SAMPLE WAS RECEIVED IN ORIGINAL PACKAGING IN REFERENCE TO SYSTEM ERROR 2240. SET WAS IN ORIGINAL PACKAGE. SET WAS PLACED ON MACHINE FOR PRIMING AND RUN WITH NO ALARMS NOTED. NO MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION. THE COMPLAINT COULD NOT BE CONFIRMED IN THE LAB. THE COMPLAINT COULD NOT BE CONFIRMED IN THE LAB. PER THE COMPLAINT INFORMATION THE ROOT CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE SUPPLY BAG FELL AND DISCONNECTED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DWELL 1. PER HOME PATIENT (HP), ONE OF THE SUPPLY BAGS HAD FALLEN AND BECOME DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH CLEARING THE ALARM AND ADVISED TO SETUP WITH NEW SUPPLIES. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE HP. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW-UP WITH THE CAREGIVER (CG), IT WAS REVEALED THAT THEY WERE UNSURE OF WHAT CAUSED THE BAG TO FALL AND DISCONNECT. THE HP WAS NOT CONNECTED AT THE TIME THE BAG FELL AND HE DID NOT RECONNECT AFTERWARDS. NEW SUPPLIES WERE USED TO COMPLETE THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 H11A02019

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HC CYCLER