BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2120996 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07501
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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 THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED BY BAXTER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S CAREGIVER ON (B)(4) 2011. ACCORDING TO THE CAREGIVER THEY DISCARDED THE SAMPLE, THEREFORE, IT IS NO LONGER AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT RECEIVING SYSTEM ERROR 2240 (AIR IN LINE) ON THE HOMECHOICE MACHINE DURING THE INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CAREGIVER (CG) CYCLE POWER AND INFORMED THE CG THEY WILL NEED TO SETUP WITH NEW SUPPLIES. PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT (HP) ON (B)(6) 2011. THE HP STATED THAT THEY HAD TO START OVER WITH NEW SUPPLIES THAT EVENING AND WERE ABLE TO FINISH THERAPY. THE HP DID NOT KNOW WHAT CAUSED THE ALARM. THE HP STATED THEY SAVED THE CASSETTE, BUT THEY DO NOT KNOW THE LOT NUMBER. THE HP SAID SHE NOTIFIED HER NURSE AND SAID SHE WAS RESUMING THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    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 - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR HOMECHOICE