BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1905580 · Received November 23, 2010

    Report

    Report Number
    1423500-2010-06111
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 31, 2010
    Report Date
    October 31, 2010
    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 COMPLAINT IS FOR A REPORT OF THE PATIENT DISCONNECTING AND NOT CAPPING THE PATIENT LINE CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE ROOT CAUSE WAS UNDETERMINED. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE 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 FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) PROBLEM OF A CAREGIVER THAT WAS REQUESTING ASSISTANCE TO END THERAPY EARLY, THIS PROBLEM OCCURRED DURING DRAIN 3 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) AS THE HP DISCONNECTED AND DID NOT CAP THE PATIENT LINE. THIS IS A REPORTABLE EVENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE CONTACTED THE CAREGIVER ON (B)(6) 2010. THE CAREGIVER STATED THE FOLLOWING: DURING DRAIN 3 OF 5 THE PATIENT DISCONNECTED TO USE THE RESTROOM AND DID NOT CAP THE LINE. UPON RETURNING THEY CONTACTED THE NURSE AND THE NURSE ADVISED THEM TO END THERAPY AND NOT RECONNECT. THE PATIENT DID NOT RECONNECT AFTER DISCONNECTING AND THEY DID NOT COMPLETE THERAPY. THE NURSE WAS AWARE OF THE MISSED THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR