BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1911952 · Received December 1, 2010

    Report

    Report Number
    1423500-2010-06414
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 6, 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). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S WIFE ON (B)(6) 2010. THE PATIENT'S WIFE STATED THAT BY MORNING THE FIBRIN HAD DISSOLVED. NO ALLEGATIONS WERE MADE AGAINST ANY BAXTER PRODUCTS. THE SAMPLES HAVE BEEN DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. THE WIFE STATED THAT SHE NOTIFIED THE NURSE OF THE FIBRIN AND AIR IN THE LINE. THE NURSE THINKS THE FIBRIN MAY HAVE JUST BEEN A MUCUS PLUG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS REPORT FOR A LOW DRAIN VOLUME ALARM WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE, THEREFORE, THE ROOT CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS NOT PERFORMED SINCE LOT NUMBER WAS NOT AVAILABLE. 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

    A PATIENT'S CAREGIVER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A LOW DRAIN VOLUME ALARM WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. THE CAREGIVER STATED THAT SHE SAW FIBRIN AND AIR BUBBLES IN THE PATIENT LINE. GTS ASKED THE CAREGIVER HOW THE ALARM WAS RESOLVED AND THE CARE STATED THAT SHE PRESSED "STOP" AND "GO." GTS REVIEWED THE PROGRAMMING AND FOUND THAT THE INITIAL DRAIN ALARM WAS SET TO 1800ML AND THE LAST FILL VOLUME WAS 2200ML. THE CAREGIVER STATED THE PATIENT DRAINED OUT 1800ML AND THAT THE HC WAS ABLE TO COMPLETE THERAPY. GTS RECOMMENDED THAT THE CAREGIVER NOTIFY THE PATIENT'S NURSE AND CALL BAXTER AT THE TIME OF THE ALARM FOR TROUBLESHOOTING ASSISTANCE. NO 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