BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2223804 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11279
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER WAS PROVIDED, A BATCH REVIEW WILL BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF PROGRAM CHANGED BY DEVICE WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT IDENTIFIED. THE DEVICE IS STILL IN SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) REGARDING A PROGRAM CHANGED BY DEVICE WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE HOME PATIENT (HP) STATED THAT HE SHOULD ONLY HAVE 4 CYCLES BUT HE NOW HAS 9. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD HP REVIEW PROGRAMMING. THERAPY=CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD)/INTERMEDIATE PERITONEAL DIALYSIS - TOTAL VOLUME EQUALED 12000ML, FILL VOLUME (FV) EQUALED 1100ML, AND LAST FILL VOLUME (LFV) EQUALED 2000ML. THE TSR EXPLAINED THAT THIS ADDS UP TO 9 CYCLES AND HP OR SOMEONE CHANGED SOMETHING IN THE PROGRAMMING. THE HP SAID HE DID NOT TOUCH THE PROGRAMMING AND HE WANTED 4 CYCLES. THE TSR EXPLAINED THAT HP WOULD NEED TO SPEAK TO HIS REGISTERED NURSE (RN) ABOUT THIS AND HAVE HER GO OVER PROGRAMMING. THE HP CLAIMS THAT HE CALLED IN THIS MORNING AND TSR CHANGED THE PROGRAMMING FOR HIM. THE TSR REVIEWED UP THE PREVIOUS CALLS AND FOUND NO PERVIOUS TSRS HAD THE PATIENT CHANGE THE PROGRAM. THE TSR EXPLAINED THIS TO HP AND THAT NONE OF THE CALLS SHOW ANY DOCUMENTATION OF PROGRAM CHANGES AND AGAIN EXPLAINED THAT IT IS AGAINST THE LAW TO CHANGE A PATIENT'S PROGRAMMING. THE HP UNDERSTOOD EXPLANATION AND WOULD CALL RN. THE HC IS OKAY. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT (HP) ON (B)(4) 2011 REGARDING THE PROGRAM CHANGED BY DEVICE. THE HP SAID THAT HE DID NOT CHANGED THE PROGRAM ON THE CYCLER. THE HP SAID THAT HE HAD ASSISTANCE ONE WITH BYPASS BUT DID NOT BYPASS THE CYCLER BY HIMSELF ANY OTHER TIME. THE HP SAID THAT HE HAD ENDED THERAPY THAT NIGHT ON THE 5TH FILL. THE HP BROUGHT THE CYCLER TO THE CLINIC THE NEXT MORNING AND IT WAS REPROGRAMMED. THE HP SAID THE CYCLES HAD NOT CHANGED AGAIN SINCE THAT DATE. THE HP SAID THAT HE WOULD CALL IN IF THIS HAPPENED AGAIN. THE HP IS CONTINUING THERAPY WITH NO FURTHER ISSUES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HOMECHOICE