BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2103618 · Received May 26, 2011

    Report

    Report Number
    1423500-2011-06560
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 1, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE SE 2240 WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. PER INITIAL INFORMATION THE PATIENT DID DISCONNECT PRIOR TO THE ALARM AND THEN RECONNECTED. 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. 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). THIS REPORT IS AN ALLEGATION AGAINST THE CASSETTE; HOWEVER, SINCE THE PRODUCT CODE IS UNKNOWN, THERE WILL NOT BE A 510K NUMBER PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER AFTERHOURS A SYSTEM ERROR (SE) 2240 ALARM DURING DRAIN 3 OF 4. THE PATIENT WAS CONNECTED TO THE MACHINE. THE PATIENT DISCONNECTED PRIOR TO THE ALARM AND THEN RECONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CUSTOMER TO CYCLE POWER TO CLEAR THE ALARM. THE TSR EXPLAINED THE SE 2240 ALARM INDICATED AIR ENTERED THE SET UP. THE TSR ADVISED THE PATIENT TO REPORT INCIDENT TO HER NURSE AND TO FINISH THERAPY MANUALLY. NO CLINICAL CONSEQUENCES OR MEDICAL INTERVENTION FOR THE PATIENT WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1