BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2231270 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11560
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 13, 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). THE SAMPLE IS BEING SENT BACK FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF A SYSTEM ERROR 2240 ALARM WAS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE THE ISSUE COULD NOT BE CONFIRMED. THE ALARM COULD NOT BE IDENTIFIED IN THE EVENT LOG OF A RETURNED DEVICE, AND THE PATIENT DID NOT DESCRIBE ANY TYPE OF USE ERROR THAT MIGHT HAVE CAUSED THE ALARM. A SAMPLE WAS RETURNED FOR EVALUATION AND THE SAMPLE WENT THROUGH PRIME AND RUN WITH NO ALARMS NOTED. NO VISUAL DEFECTS FOR LEAKS WERE IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DWELL 3 OF 3. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CYCLE POWER. THE HP STATED SHE DISCONNECTED HERSELF WHEN THE HC ALARMED. THE TSR ADVISED THE HP THAT THERAPY HAS ENDED AND WOULD NEED TO EITHER START OVER WITH NEW SUPPLIES OR DO A MANUAL EXCHANGE. THE TSR ADVISED THE HP TO INFORM THE PERITONEAL DIALYSIS NURSE OF THE SYSTEM ERROR. THE HP WOULD DO A MANUAL EXCHANGE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) ON (B)(6) 2011 REGARDING THE REPORTED SYSTEM ERROR. THE HP STATED THAT HER HUSBAND NOTICED, DURING PRIMING, THERE WAS A "HICCUP" IN THE PATIENT LINE, BUT WHEN HE HOOKED HER UP, EVERYTHING WAS PRIMED CORRECTLY. THE HP STATED THAT OTHER THAN THAT, NOTHING LOOKED UNUSUAL. THE HP STATED THAT SHE FINISHED THERAPY WITH MANUAL SUPPLIES. THE HP STATED THAT SHE HAD NO FURTHER PROBLEMS AFTER THAT AND WAS CONTINUING THERAPY FINE.

    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 51 YR HOMECHOICE