BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 2241933 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11998
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K833065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR USE ERROR WAS CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE USE ERROR WAS NOT DETERMINED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK LINES AND BAGS ALARM, WHICH OCCURRED ON THE HOMECHOICE PRO (HCP) DURING USE DURING PRIME. THE PATIENT WAS NOT CONNECTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE PATIENT PERFORM MULTIPLE TROUBLESHOOTING STEPS. THE TSR HAD THE PATIENT DISCONNECT THE TWO, TWO-DAY OLD DRAIN LINE EXTENSIONS. WHILE DISCONNECTING THE EXTENSIONS THE PATIENT OBSERVED THAT THERE WAS A CLOSED CLAMP. THE PATIENT OPENED THE CLAMP AND THE HCP PRIMED. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN) ON (B)(6) 2011 REGARDING THE REPORT OF THE PATIENT REUSING THEIR DRAIN LINE EXTENSIONS. THE RN STATED THEY WERE AWARE THE PATIENT HAD REUSED THEIR DRAIN LINE EXTENSIONS. BAXTER PRODUCT SURVEILLANCE RECOMMENDED THE RN REVIEW PROPER PROCEDURES WITH THE PATIENT AS THE DRAIN LINE EXTENSIONS ARE RECOMMENDED FOR SINGLE USE. THE RN STATED THE PATIENT WAS CONTINUING THERAPY ON THE CYCLER SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HOMECHOICE PRO