BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2173579 · Received July 23, 2011

    Report

    Report Number
    1423500-2011-09347
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 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). A REQUEST FOR THE DEVICE HAS BEEN MADE; HOWEVER, IT WAS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT COULD NOT BE DETERMINED. 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (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 DWELL 2 OF 3. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND HAD THE PATIENT CLOSE THE CLAMPS AND CYCLE THE POWER TO CLEAR BOTH THE SE 2240 AND SE 2367. THE TSR ADVISED THE PATIENT TO DISCARD THE SUPPLIES AND FINISH WITH MANUALS. THE TSR REVIEWED THE PROPER PROCEDURES PER THE USER MANUAL WITH THE PATIENT. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2011 REGARDING THE REPORTED SE 2240. THE PATIENT STATED THEY DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE SUPPLIES IN USE AND DID NOT KNOW HOW AIR MIGHT HAVE GOT INTO THE LINES. THE PATIENT STATED THEY TALKED TO THEIR NURSE ABOUT THE ALARM AND THERAPY HAS BEEN GOING FINE SINCE THEN. THERE WAS NO PATIENT 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 H11B18039

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOMECHOICE