BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2241977 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-12014
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 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 REPORT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS A LEAK IN THE DISPOSABLE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CAREGIVER (CG) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN SET), WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING DWELL 3 OF 4. THE PATIENT WAS CONNECTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CG CYCLE THE POWER AND A SE 2367 OCCURRED. THE TSR HAD THE CG CYCLE THE POWER AGAIN TO THE PRESS GO TO START PROMPT. THE TSR HAD THE CG DISCONNECT THE PATIENT, REMOVE THE CASSETTE, AND DISCARD THE SUPPLIES. THE TSR EXPLAINED THE ALARM, REVIEWED PROPER PROCEDURES PER THE USER MANUAL, AND ADVISED THE CG TO CONTACT THE NURSE. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2011 REGARDING THE REPORTED SE 2240. WHEN ASKED IF THE PATIENT NOTICED ANYTHING UNUSUAL WITH THE SUPPLIES, THE PATIENT STATED THAT THEY NOTICED THERE WAS A PIN-SIZED HOLE IN ONE OF THE BAGS AND HOLE SEEMED TO GET LARGER AS THERAPY PROGRESSED. THE PATIENT THOUGHT THAT THIS MIGHT HAVE CAUSED AIR TO GET INTO THE LINES. THE PATIENT STATED THEY FINISHED THERAPY USING MANUAL SUPPLIES. THE PATIENT STATED THEY SPOKE WITH THEIR NURSE ABOUT THE ALARM AND HAS BEEN CONTINUING THERAPY ON THE CYCLE SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HOMECHOICE