BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2031888 · Received March 28, 2011

    Report

    Report Number
    1423500-2011-03741
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 4, 2011
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORT OF AIR 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE PATIENT HAD DISCONNECTED HIMSELF PRIOR TO ALARM. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR A USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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 HOME PATIENT (HP) REPORTED THROUGH BAXTER'S AFTERHOURS CALL SERVICE A SYSTEM ERROR 2240 ALARM THAT OCCURRED ON THE HOMECHOICE MACHINE DURING DRAIN 4 OF 4. THE HP STATED SHE WAS CONNECTED TO THE MACHINE AT THE TIME OF THE ALARM; HOWEVER, HAD DISCONNECTED PRIOR TO THE ALARM. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE