BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2111910 · Received June 2, 2011

    Report

    Report Number
    1423500-2011-07017
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 8, 2011
    Report Date
    May 8, 2011
    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). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE ALARM IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. LABELING REVIEW FINDS THE LABELING ADEQUATE FOR THE USE ERROR IDENTIFIED 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 CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING SYSTEM ERROR 2240 (AIR IN LINE) ALARM ON THE HOMECHOICE (HC) MACHINE DURING DRAIN 2 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) AND ADVISED THE CAREGIVER (CG) THAT AIR HAS ENTERED SETUP. THE TSR HAD THE CG RECYCLE POWER. TSR ADVISED THE CG THAT THERAPY HAS ENDED AND WILL NEED TO START OVER WITH NEW SUPPLIES OR DO MANUAL EXCHANGE. THE HP DISCONNECTED SELF DURING DWELL AND WHEN RETURNED PRESSED GO WITHOUT CONNECTING SELF. HP ALSO HAD TRANSFER SET OPEN AND PATIENT LINE DID NOT HAVE FLEXICAP (ADDRESSED SEPARATELY) ON IT WHEN SHE DISCONNECTED. THE TSR ADVISED CG THEY WILL NEED TO CALL THE NURSE TO INFORM. THE TSR EXPLAINED TO THE CG WHEN HP DISCONNECTS DURING DWELL NEEDS TO CLOSE PATIENT LINE CLAMP, PLACE FLEXICAP ON PATIENT LINE, CLOSE TRANSFER SET AND PLACE CAP ON CATHETER ALSO. BAXTER PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011. THE HP STATED THAT THE ISSUE WAS RESOLVED BY ENDING THERAPY AND STARTING WITH NEW SUPPLIES. PER HP, SHE DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT, THE HP HAS NOT NOTIFIED THE NURSE OF THE ALARM. THE HP STATED THAT SHE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR HOMECHOICE