BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1903698 · Received November 20, 2010

    Report

    Report Number
    1423500-2010-06010
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    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 LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. 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). ADDITIONAL INFORMATION: 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. THIS COMPLAINT FOR A LOW DRAIN VOLUME ALARM (LDVA) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. PER THE COMPLAINT INFORMATION, THE PATIENT DID NOT CHECK THE PATIENT LINE TO VERIFY THAT PRIME HAD COMPLETED PRIOR TO CONNECTING WHICH CAUSED AIR TO GET INTO THE SET UP. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION OF THE LDVA IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A HOME PATIENT'S (HP) CAREGIVER (CG) REPORTED A LOW DRAIN VOLUME ALARM THAT APPEARED ON THE HOMECHOICE DISPLAY DURING INITIAL DRAIN. THE CG REVEALED THAT THE PATIENT LINE DID NOT PRIME DUE TO NOT OPENING THE CLAMP DURING PRIME. FURTHERMORE, THE HP HAD REPORTEDLY CONNECTED HIMSELF WITH THE AIR IN THE PATIENT LINE. THE CG WANTED ASSISTANCE TO REPRIME THE PATIENT LINE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE CG WOULD NEED TO END THE THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR THEN EXPLAINED THAT THE CG SHOULD NOT GO BACK AND REPRIME PATIENT LINE ONCE THE HP HAD CONNECTED. THE TSR ASSISTED THE CG END THERAPY. THE CG WOULD START OVER WITH NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    DURING A FOLLOW UP WITH THE HOME PATIENT (HP)'S WIFE REGARDING THE REPORTED ISSUE, IT WAS REVEALED THAT THE AIR WAS IN THE DRAIN LINE AND NOT THE PATIENT LINE. THE HP'S WIFE STATED THAT SHE NORMALLY IS WITH THE HP WHEN SETTING UP FOR THERAPY BUT THAT PARTICULAR NIGHT SHE WAS DOING SOMETHING ELSE AND THE HP DECIDED TO START SETTING UP WITHOUT HER AND HE GOT DISTRACTED. THE HP'S WIFE STATED THAT THEY DID DISCUSS THIS WITH THE NURSE AND THAT IT WAS AN ISOLATED EVENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1