BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2052233 · Received April 12, 2011

    Report

    Report Number
    1423500-2011-04399
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 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 FOR EVALUATION; THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW WILL NOT BE PERFORMED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR CONNECTION ISSUE WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS DETERMINED TO BE SUPPLY BAG DISCONNECTED WITHOUT FALLING. 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

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED THAT THE FINAL BAG BECAME DISCONNECTED DURING DWELL 4 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CAREGIVER (CG). THE CG STATED THAT THE FINAL BAG DISCONNECTED AND FELL TO THE FLOOR DURING DWELL. THE CG PUT THE HP INTO A MANUAL DRAIN AND DRAINED OUT 1087ML. THE TSR HAD THE CG CYCLE POWER ON MACHINE TO END OF THERAPY AND ADVISED TO CONTACT THE NURSE. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(4) 2011. THE PATIENT STATED THAT THE BAG NEVER FELL, HOWEVER, THE LINE FELL OUT OF THE BAG PORT WHILE THE PATIENT WAS SLEEPING. THE PATIENT STATED SHE HAD CONTACTED THE NURSE REGARDING THE EVENT AND IS USING ANTIBIOTICS IN A MANUAL DRAIN TO PREVENT INFECTION. NO PATIENT INJURY 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 - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR HOMECHOICE