BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2180562 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09809
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 10, 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 DUE TO USE ERROR, THE PATIENT CONNECTOR LINE WAS LOWER THAN THAT OF THE HEATER BAG. THE FLUID LEVEL IS TO BE AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE BEFORE CONNECTING THE DISPOSABLE SET TO THE PATIENT. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USE ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAD CONDUCTED A TREND REVIEW AND FOUND SIMILAR REPORTS HAD BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING REPRIMING THE PATIENT LINE; WHICH OCCURRED ON THE HOMECHOICE DURING USE, DURING PRIME. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) WITH REPRIMING THE PATIENT LINE AS REQUESTED. THE SOLUTION OVERFLOWED FROM THE PATIENT LINE A LITTLE BIT. THE HP CONNECTED AND STARTED THERAPY. THIS WRITER CONTACTED THE HOME PATIENT (HP) (B)(6) 2011 REGARDING THE REPORTED PROBLEM. THE PATIENT STATED THAT THEY HAD SOME ISSUES WITH THE OVER FLOW DURING PRIME EVEN BEFORE THEY CALLED IN. THE HP STATED THE PROBLEM WAS THEY HAD THE LINE TOO LOW VERSES THE MACHINE. THE HP STATED THEY ALSO HAD AIR IN THE PATIENT LINE AS WELL AND THAT WHY THEY CALLED TO GET ASSISTANCE WITH REPRIMING, BUT THEY HAD THIS BECAUSE THE CASSETTE DOOR WAS NOT CLOSED ALL THE WAY ALONG WITH THE PATIENT LINE WAS TOO HIGH VERSE THE HEATER BAG. THEY STATED THEY DID NOT NOTICE THAT THE MACHINE WAS DISPLAYING "DOOR NOT CLOSED". THE HP STATED THEY DID NOT NOTICE ANYTHING UNUSUAL WITH THE MACHINE OR WITH THE DISPOSABLES THEMSELVES, THEY STATED THIS WAS ALL DUE TO THEIR ERROR. THE HP STATED THERAPY IS GOING FINE SINCE THE REPORTED PROBLEM. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 43 YR HOMECHOICE