BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REN - HARDWARE

    MDR report key: 1996772 · Received February 19, 2011

    Report

    Report Number
    1423500-2011-02181
    Event Type
    Malfunction
    Date Received
    February 19, 2011
    Date of Event
    October 20, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION TO THE PRODUCT ANALYSIS LAB. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS UNDETERMINED. 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

    BAXTER GLOBAL PHARMACOVIGILANCE FORWARDED A TELEPHONE CONTACT REPORT TO CORPORATE PRODUCT SURVEILLANCE EMAILBOX FOR A HOME PATIENT (HP). AN INCREASED INTRA-PERITONEAL VOLUME (IIPV), OVERFILL EVENT OCCURRED ON (B)(6) 2010 DURING THE LAST DRAIN. THE HP REPORTED FELT FULL. THE LAST FILL VOLUME WAS 1500ML AND A MANUAL DRAIN WAS PERFORMED, DRAIN VOLUME 3L. THE HP WAS DOING OK AND DID NOT REQUIRE HOSPITALIZATION. THE NURSE WOULD FOLLOW UP WITH THE HP ON (B)(6) 2010. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE NURSE TO CONFIRM THE LAST FILL VOLUME INFORMATION THAT WAS DOCUMENTED ON THE TELEPHONE CONTACT REPORT DATED (B)(6) 2010. THE NURSE CONFIRMED THAT THE LAST FILL VOLUME AND THE LARGEST PRESCRIBED FILL VOLUME WAS 1500CC. NO FURTHER INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REN - HARDWARE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR