BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1940043 · Received December 29, 2010

    Report

    Report Number
    1423500-2010-07341
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 5, 2010
    Report Date
    December 5, 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). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) DURING INITIAL DRAIN WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER INCOMPLETE PRIMING. THE HP STATED THAT SHE DID NOT CHECK THE PATIENT LINE PRIOR TO CONNECTING AND ALSO USES A PATIENT LINE EXTENSION. THE HP STATED SHE DID NOT REMEMBER IF SHE CONNECTED THE EXTENSION LINE BEFORE THE START OF PRIME. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. 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) CONTACTED GLOBAL TECHNICAL SERVICES TO REPORT A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING INITIAL DRAIN. THE HP STATED THAT SHE DID NOT CHECK THE PATIENT LINE PRIOR TO CONNECTING AND ALSO USES A PATIENT LINE EXTENSION. THE HP STATED SHE DID NOT REMEMBER IF SHE CONNECTED THE EXTENSION LINE BEFORE THE START OF PRIME. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED PROPER SETUP PROCEDURE AND ASSISTED THE HP TO DISCONNECT USING ASEPTIC TECHNIQUE. THE TSR FURTHER ASSISTED THE HP TO CYCLE POWER TO CLEAR THE ALARM. THE HP CONFIRMED TO START OVER WITH NEW SUPPLIES. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP'S NURSE WHO CONFIRMED SHE ALREADY SPOKE WITH THE HP ABOUT THE INCIDENT. THE NURSE STATED THAT THE HP DID NOT DEVELOP ANY INFECTION FROM THE INCIDENT. THE NURSE ADVISED THE HP HAS RESUMED THERAPY WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HOMECHOICE APD CYCLER