BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2102361 · Received May 25, 2011

    Report

    Report Number
    1423500-2011-06457
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 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 NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. AS PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE DOG BITE THROUGH THE PATIENT LINE. PER THE HOME PATIENT (HP), HER DOG BIT THROUGH THE LINE AND CAUSED THE ALARM. 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. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON HOME CHOICE (HC) DURING USE DURING DRAIN 2 OF 3. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) RECYCLED POWER, CLEARED AND EXPLAINED THE ALARMS. THE HOME PATIENT (HP) WILL DISCARD SUPPLIES AND FINISH WITH MANUALS. THE HP STATED THAT THE DOG BIT THROUGH THE PATIENT LINE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. PER THE HP, HER PUPPY BIT THROUGH THE LINE AND CAUSED THE ALARM. THE HP STATED SHE DOES NOT ALLOW HIM IN THE ROOM WITH HER ANYMORE DURING THERAPY. THE HP STATED SHE DID CONTACT HER PD RN AND LET HER KNOW ABOUT THE ALARM AND THE HP HAD TO PUT MEDICATION IN THE BAG AS A PRECAUTION. THE HP STATED SHE FINISHED WITH MANUALS THE FOLLOWING DAY AND THEN RESUMED THERAPY ON THE CYCLER THE FOLLOWING NIGHT. NO PATIENT INJURY WAS 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 62 YR