BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1850761 · Received October 2, 2010

    Report

    Report Number
    1423500-2010-04020
    Event Type
    Malfunction
    Date Received
    October 2, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING INITIAL DRAIN 1 OF 5 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE CAREGIVER STATED THAT THE PATIENT HAD NOT DISCONNECTED SINCE THE START OF THERAPY AND THERE WAS AIR VISIBLE IN THE PATIENT LINE FROM THE DOOR ALL THE WAY TO THE TRANSFER SET. THE CAREGIVER CONFIRMED THAT THE CONNECTION WAS TIGHT AND HE WAS UNABLE TO FIND ANY LEAKS IN THE TUBING. THE CAREGIVER ALSO STATED THE PATIENT USES EXTENSION LINE AND BOTH WERE CONNECTED PRIOR TO THE START OF PRIME. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. LABEL REVIEW WAS NOT PERFORMED NO USER ERROR WAS SUSPECTED. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CAREGIVER (CG) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING DRAIN 1 OF 5. THE CG STATED THAT THE HOME PATIENT (HP) HAD NOT DISCONNECTED SINCE THE START OF THERAPY AND THERE WAS AIR VISIBLE IN THE PATIENT LINE FROM THE DOOR ALL THE WAY TO THE TRANSFER SET. THE CG CONFIRMED THAT THE CONNECTION WAS TIGHT. THE CG STATED HE WAS UNABLE TO FIND ANY LEAKS IN THE TUBING. THE CG STATED THE HP USES 2 PATIENT LINE EXTENSIONS AND BOTH WERE CONNECTED PRIOR TO THE START OF PRIME. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO CYCLE POWER TWICE TO CLEAR ALARM. THE TSR ALSO ADVISED THE CG TO CONTACT THE PERITONEAL DIALYSIS NURSE (PDRN) TO HAVE TRANSFER SET CHECKED FOR LEAKS OR DAMAGE. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE HP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ON (B)(6) 2010, PRODUCT SURVEILLANCE CONTACTED THE CG. THE CG REPORTED NO FURTHER ISSUES; NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR