BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2550111 · Received April 26, 2012

    Report

    Report Number
    1423500-2012-09757
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Date of Event
    April 8, 2012
    Report Date
    April 8, 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). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF USE ERROR, REUSE OF A SINGLE USE PRODUCT WAS CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A CHECK SUPPLY LINE ALARM WHICH OCCURRED ON THE HOME CHOICE (HC) DURING PRIME. THE CAREGIVER (CG) STATED THAT THE HOME PATIENT (HP) WAS IN A DRAIN CYCLE WHEN THE SUPPLY LINE BECAME DISCONNECTED AND WANTED TO KNOW IF THEY COULD JUST CONNECT THE LINE SINCE IT DID NOT TOUCH THE FLOOR. THE HC STARTED ALARMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED WHAT THE SCREEN WAS SAYING, AND THE CG STATED 'CHECK THE SUPPLY LINE/PRIMING'. THE TSR ASKED THE CG IF THEY HAD STARTED OVER WITH NEW SUPPLIES AND WERE GETTING THAT ERROR. THE CG SAID THAT THEY NEVER STARTED OVER AND THAT THEY DID NOT DO ANYTHING TO THE MACHINE. THE TSR HAD THE CG CYCLE THE POWER ON THE HC AND THEN GO TO THE ALARM LOG. THE HC ALARMED SYSTEM ERROR 2240 AND SYSTEM ERROR 2367 AND AFTER THAT IT SHOWED CHECK THE SUPPLY LINE 6 TIMES. THE CG DID START THERAPY OVER THAT MANY TIMES BUT NEVER CHANGED THE SUPPLIES. THE TSR INSTRUCTED THE CG TO START OVER WITH NEW SUPPLIES AND ASSISTED THE CG TO END THERAPY FROM WHERE THEY WERE. THE TSR REFERRED THE CG TO THE PATIENT'S PERITONEAL DIALYSIS REGISTERED NURSE REGARDING THE AIR IN THE LINES AND THE HP STILL BEING CONNECTED THROUGH 6 DIFFERENT PRIME ALARMS. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT LINE WAS PROPERLY PRIMED PRIOR TO CONNECTING AND THERE WERE NO PATIENT LINE EXTENSIONS BEING USED. THE PATIENT HAD NOT DISCONNECTED PRIOR TO THE ALARM. THE SUPPLIES WERE NOT DAMAGED BY AN OUTLET PORT CLAMP OR AN ASSIST DEVICE USED TO MAKE CONNECTIONS. A SUPPLY BAG HAD FALLEN AND DISCONNECTED FROM THE SUPPLY LINE. PROPER PROCEDURES WERE REVIEWED WITH THE PATIENT. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE (BPS) CONTACTED THE CG ON (B)(4) 2012. HE STATED THAT THE SUPPLY BAG HAD FALLEN OFF DURING THE DRAIN CYCLE DUE TO USE ERROR ALONE. THE BAG HAD NOT BEEN CONNECTED PROPERLY. THE CG DID NOT NOTICE THIS, AND HAD TRIED TO RESTART THERAPY USING THE SAME SUPPLIES. HE EVENTUALLY NOTICED THE BAG, AND THAT'S WHEN HE CALLED IN TO BAXTER. THE CG HAD SPOKEN TO THE PATIENT'S NURSE ABOUT THE EVENT AND THE USER ERRORS OF BEING CONNECTED DURING PRIME AND REUSING SUPPLIES, AND PROPER PROCEDURES WERE REVIEWED. THE PATIENT WAS CURRENTLY PERFORMING HEMODIALYSIS AS "TOO MUCH SUGAR" HAD BUILT UP "ON HER MEMBRANE", BUT WOULD RETURN TO USING PERITONEAL DIAYLSIS AS SOON AS THIS CLEARED UP. THERAPY SINCE HAS BEEN GOING WELL, AND THERE WERE NO ADVERSE EVENTS REPORTED IN RELATION TO THIS EVENT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HOMECHOICE