BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1912000 · Received December 1, 2010

    Report

    Report Number
    1423500-2010-06427
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 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). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A CHECK LINES AND BAGS ALARM. THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. A BATCH REVIEW WAS NOT PERFORMED BECAUSE LOT INFORMATION WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT WAS DUE TO AN EMPTY BAG. THERE WAS USE ERROR IDENTIFIED DURING TROUBLESHOOTING; THE PATIENT UNSPIKED THE BAG DURING SET UP AND RECONNECTED IT. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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

    THE HOME PATIENT (HP) CONTACTED (B)(4) REGARDING A CHECK LINES AND BAGS ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING REFILLING THE HEATER IN LAST FILL. THE HP STATED THE BAGS WERE EMPTY. THE HP STATED THAT SHE ACCIDENTALLY UNSPIKED THE BAG DURING SET UP AND RECONNECTED IT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HELPED THE HP END THERAPY PER HP REQUEST. THE HP CONFIRMED TO CONTACT HER NURSE (RN) REGARDING REUSING THE BAG THAT WAS RECONNECTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2010 (B)(4) CONTACTED THE HP WHO STATED SHE NOTIFIED HER NURSE OF THE EVENT WHO PROVIDED HER WITH (B)(6). THE HP STATED SHE WAS ABLE TO RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention