BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2032796 · Received March 29, 2011

    Report

    Report Number
    1423500-2011-03792
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) REGARDING THE ALARM. THE HP STATED THAT HE WAS ABLE TO START OVER WITH NEW SUPPLIES. THERE WAS NO LOT NUMBER PROVIDED AND THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED. 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. A BATCH REVIEW CANNOT BE PERFORMED SINCE A LOT NUMBER WAS NOT PROVIDED. 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 A SYSTEM ERROR 2240 (AIR IN LINE) ALARM ON THE HOME CHOICE (HC) MACHINE DURING DWELL 5 OF 7. THE HOME PATIENT (HP) STATED THAT HE IS STILL CONNECTED TO THE HC. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE POWER, DISCONNECT, REMOVE THE CASSETTE, AND DISCARD THE SUPPLIES. THE TSR ADVISED THE HP TO CONTACT THE NURSE. THE HP WILL START THERAPY WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. 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 - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE