BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1891411 · Received November 4, 2010

    Report

    Report Number
    1423500-2010-05267
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 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). 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 NOT DETERMINED. THERE WAS USE ERROR IDENTIFIED DURING TROUBLESHOOTING; THE PATIENT STATED THAT THE DRAIN LINE WAS NOT NEW TONIGHT INDICATING THAT THE DRAIN LINE WAS BEING REUSED. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION WAS RESOLVED OVER THE PHONE; NO SAMPLE WAS REQUESTED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK LINES AND BAGS ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING PRIMING. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) ASSISTED THE HP WITH TROUBLESHOOTING. THE HP REMOVED THE DRAIN LINE EXTENSION AND THE DRAIN INTO THE BUCKET. THE ALARM CLEARED. THE TSR ADVISED THE HP TO CONTINUE THERAPY WITHOUT THE EXTENSION AND DRAIN INTO THE BUCKET. THE HP STATED THAT THE DRAIN LINE EXTENSION WAS NOT NEW THAT NIGHT. THE TSR ADVISED THE HP TO USE A NEW EXTENSION LINE WITH EACH SETUP. THE HP RESUMED SETUP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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 61 YR