BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1983945 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01748
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    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 REPORT OF A CHECK PATIENT LINE WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. A BATCH REVIEW WAS NOT PERFORMED AS LOT INFORMATION WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE LOT NUMBER IS UNKNOWN AT THIS TIME. THE SAMPLE IS UNAVAILABLE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK PATIENT LINE ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING DRAIN 1 OF 3. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HELPED THE HOME PATIENT (HP) TO CHECK THE SETUP. THE HP FOUND NO KINKS CLOSED CLAMP OR AIR IN LINES, BUT ALARM REPEATED. THE TSR ENDED THERAPY EARLY AND WALKED THE HP THROUGH A MANUAL PRIME. THE HP FOUND THAT CASSETTE WAS FULL OF AIR. MANUAL PRIME PURGED THE AIR FROM THE SETUP. THE TSR THEN HELPED THE HP TO COMPLETE A PRIME ON THE UNIT. THE HP WILL RESTART WITH THE INITIAL DRAIN COMPLETING THE DRAIN FROM THE PRIOR THERAPY DURING THE INITIAL DRAIN. THE HC REPEATED THE ALARM AFTER PRIME WAS COMPLETE. THE HP WILL TRY A MANUAL EXCHANGE TO DRAIN IF IT DOES NOT DRAIN. THE HP WILL CONTACT THE PERITONEAL DIALYSIS NURSE FOR INSTRUCTION. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THIS REPORTED PROBLEM. WRITER SPOKE WITH THE RN. SHE STATED THAT SHE WAS AWARE OF THE REPORTED AIR AND CHECK PATIENT LINE ALARM. SHE STATED THAT THE ISSUE WAS RESOLVED AND THAT THERAPY WAS GOING WELL FOR THE HP. SHE STATED THAT THE AIR WAS RELATED TO THE HP BEING CONSTIPATED, AND NOT THE HC MACHINE. THE RN STATED THAT NO INJURIES/MEDICAL INTERVENTION WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    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 58 YR HOMECHOICE APD SYSTEM/REF (B)(4)