BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2150735 · Received July 6, 2011

    Report

    Report Number
    1423500-2011-08705
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 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). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) OCCURRED DURING DWELL 2 WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE ROOT CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THERE WAS AN OPEN CLAMP ON UNUSED SUPPLY LINE. THE CAUSE WAS USE ERROR. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SPECIFIC PRODUCT CODE FOR THE HOMECHOICE AUTOMATED PD SET WITH CASSETTE IS UNKNOWN. THE DEVICE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER (B)(4) REGARDING ASSISTANCE WITH THE HOMECHOICE (HC) UNIT DURING DWELL 2. PER THE INITIAL REPORT, THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2240. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CLOSE ALL THE CLAMPS AND THE TRANSFER SET. THE TSR HAD THE HP CYCLE THE POWER OFF AND ON. THE HC THE HAD A SYSTEM ERROR 2367. THE TSR HAD THE HP CYCLE THE POWER OFF AND ON TO THE "PRESS GO TO START" PROMPT. THE TSR EXPLAINED THE ALARMS AND THE HP STATED SHE FORGOT TO CLOSE OFF THE EXTRA LINE CLAMPS WHICH CAUSED THE SYSTEM ERROR 2240 IN DWELL 2. THE TSR EXPLAINED TO DISCARD ALL THE SUPPLIES AND TO REPORT THE ALARMS TO THE PERITONEAL DIALYSIS NURSE THE FOLLOWING MORNING. THE HP FINISHED THE NIGHT'S THERAPY MANUALLY. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. BAXTER (B)(4) CONTACTED THE HP ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240. THE HP STATED THAT THE ISSUE WAS RESOLVED BY ENDING THERAPY AND CONTINUING WITH MANUALS. THE CAUSE OF THE ALARM WAS DUE TO LEAVING THE FINAL LINE CLAMP OPEN. THE HP VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. PER THE HP, SHE DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE HP STATED THAT SHE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE HP STATED THAT SHE HAD DISCARDED THE SUPPLIES AFTER THERAPY, AND DID NOT KNOW THE LOT NUMBERS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO FURTHER INFORMATION WAS PROVIDED.

    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 57 YR HOMECHOICE