BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2141686 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08410
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 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). THE SAMPLE IS NOT AVAILABLE; THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW WILL NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS CONFIRMED. BASED ON INFORMATION PROVIDED BY THE PATIENT, THE CAUSE WAS IDENTIFIED AS THE SUPPLY BAG DISCONNECTING AFTER FALLING. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING SYSTEM ERROR 2240 (AIR IN LINE) ALARM ON THE HOMECHOICE (HC) MACHINE DURING DWELL 3 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP). THE HP STATED THAT THE SUPPLY BAG FELL AND DISCONNECTED. THE TSR HAD THE HP CYCLE POWER AND RETRIEVE THE CASSETTE. THE TSR ADVISED THE HP TO NOTIFY THE NURSE OF THE ALARM. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2011. THE NURSE STATED THAT THEY SPOKE TO THE PATIENT REGARDING THE ALARM. THE NURSE STATED THEY DID NOT CONTINUE THERAPY THAT NIGHT; THEY JUST ENDED IT FOR THE EVENING. THE NURSE STATED THERAPY HAS BEEN CONTINUING FINE WITHOUT FURTHER PROBLEMS. THE NURSE STATED THAT THE HP HAS CORRECTED THEIR SETUP SO THIS SITUATION DOES NOT REOCCUR. 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 58 YR HOMECHOICE