BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2013904 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-03023
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 2, 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/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING INITIAL DRAIN WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE MOST LIKELY CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE PATIENT EXTENSION LINE WAS CONNECTED AFTER PRIMING WAS COMPLETE OR THE CLAMP ON PATIENT LINE WAS NOT OPEN DURING THE PRIMING. THE HP STATED HE DID NOT HAVE THE PATIENT EXTENSION LINE ON OR THE PATIENT CLAMP OPEN DURING THE PRIMING. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION. 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 RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING INITIAL DRAIN. THE HP STATED HE DID NOT HAVE THE PATIENT EXTENSION LINE ON OR THE PATIENT CLAMP OPEN DURING THE PRIMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED IN CLEARING THE ALARM THEN EXPLAINED A SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP AND HAD THE HP END THERAPY. THE HP STATED THEY WOULD USE MANUAL SUPPLIES FOR TONIGHT. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE HP. THE PATIENT WAS INVOLVED, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. A FOLLOW UP WAS MADE VIA PHONE CALL. THE HP HAS CONTINUED THERAPY WITH NO INJURY OR MEDICAL INTERVENTION REPORTED AS A RESULT OF THIS INCIDENT.

    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 62 YR HOMECHOICE