BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2180432 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09742
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 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 INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION AGAINST ANY BAXTER PRODUCTS. NO EVALUATION OF THE DEVICE NOR BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A USE ERROR OCCURRED WHEN THE PATIENT DISCONNECTED THE SOLUTION BAGS FROM THE SUPPLY LINE DURING A CHECK LINES AND BAGS ALARM DURING PRIME, WAS CONFIRMED BASED ON INFORMATION PROVIDED BY THE PATIENT. THE CAUSE WAS USE ERROR. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. 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

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A HOME CHOICE (HC) ALARM SITUATION AND THE CAREGIVER (CG) REPORTED THAT SHE DISCONNECTED THE BAGS TO SEE IF THE SOLUTION WOULD COME OUT. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED THAT THE SUPPLIES WERE COMPROMISED AND ADVISED THE CG TO START OVER WITH NEW SUPPLIES. THE CG UNDERSTOOD THE EXPLANATION AND WOULD START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011 REGARDING THE ALARM AND THE DISCONNECTION OF THE SOLUTION BAGS DURING PRIME. PER THE HP, THE BAGS WERE DISCONNECTED TO SEE IF THEY WERE FLOWING AS THEY SHOULD AND THEY DID NOT SEE ANYTHING. THE HP STATED THEY STARTED OVER WITH NEW SUPPLIES AND RESUMED THERAPY. PRODUCT SURVEILLANCE ADVISED THE HP THAT IT IS NOT RECOMMENDED THAT THE SUPPLIES BE DISCONNECTED AT ANYTIME, AS THE SET IS THEN CONTAMINATED AND SHOULD BE DISCARDED. THE HP UNDERSTOOD. THERE WAS PATIENT INVOLVEMENT, BUT 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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR HOMECHOICE