BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2073178 · Received April 29, 2011

    Report

    Report Number
    1423500-2011-05223
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 16, 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). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT WAS NOT CONFIRMED. PER THE COMPLAINT INFORMATION, THE MOST LIKELY CAUSE OF THE COMPLAINT IS USE ERROR. LABEL REVIEW WAS PERFORMED AND THE 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING DISCONNECTING AND RECONNECTING HIS SUPPLY BAG, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING FILL. THE HOME PATIENT (HP) STATED THAT HE RECONNECTED THE SUPPLY BAG TO THE UNUSED LINE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED ABOUT NOT RECONNECTING SUPPLY BAGS AND ASSISTED THE HP TO END THERAPY. THE TSR ADVISED THE HP TO LET THE REGISTERED NURSE (RN) KNOW ABOUT RECONNECTING THE SUPPLY BAG AND NOT COMPLETING THERAPY. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. A FOLLOW UP WAS DONE VIA PHONE. THE HP STATED THAT THE BAG WAS NOT FILLING THE HEATER BAG SO HE DISCONNECTED IT AND ADDED ANOTHER BAG. THE HP STATED AT THAT TIME HE DID NOT NOTICE ANYTHING WITH THE BAG THAT COULD HAVE CAUSED THE ISSUE. THE HP STATED THAT THE SAMPLE WAS DISCARDED AND THE LOT NUMBERS WERE UNKNOWN. THE HP STATED HE SPOKE WITH HIS REGISTERED NURSE (RN) ABOUT DISCONNECTING AND RECONNECTING BAGS AND THE RN TOLD THE HP NOT TO DO THAT. THE HP STATED THERAPY IS GOING FINE SINCE THEN. 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 84 YR HOMECHOICE