BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2173573 · Received July 23, 2011

    Report

    Report Number
    1423500-2011-09345
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 26, 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). 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. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION OR SHOULD ADDITIONAL INFORMATION BE OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING INITIAL DRAIN WAS CONFIRMED. LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH CAPA RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING INITIAL DRAIN. THE HOME PATIENT (HP) WAS CONNECTED TO THE MACHINE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CLOSE ALL THE CLAMPS AND CYCLE POWER OFF AND ON. THERE WAS A SYSTEM ERROR (SE) 2367 THAT OCCURRED. THE TSR HAD THE HP CYCLE POWER OFF AND ON AND THE ALARM CLEARED. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES AND LET THE REGISTERED NURSE (RN) KNOW OF THE AIR DETECT ALARM. THE ALARM WAS CLEARED. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT, BUT NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. BAXTER PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) ON (B)(6) 2011 REGARDING THE REPORTED PROBLEM. THE HP STATED THAT HE HAD SKIPPED THE PRIMING STAGE AND THAT IS WHAT CAUSED THE AIR IN THE LINES. THE HP STATED THAT HE HAS A VISION PROBLEM AND THEREFORE, SOMETIMES HE MAKES MISTAKES DURING THERAPY WHICH RESULT IN THESE ALARMS. THE HP DID NOTIFY HIS REGISTERED NURSE (RN) REGARDING THE ALARM AND THE RN DID REVIEW PROPER THERAPY PROCEDURE WITH THE HP. THE HP WAS CONTINUING THERAPY WITHOUT ANY OTHER COMPLICATIONS. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    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 50 YR HOMECHOICE