BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1914753 · Received December 3, 2010

    Report

    Report Number
    1423500-2010-06515
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A CONNECTION ISSUE. THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. A BATCH REVIEW WAS NOT PERFORMED BECAUSE LOT INFORMATION WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT WAS DUE TO USE ERROR. THE PATIENT STATED SHE CONNECTED THE PATIENT LINE INCORRECTLY WHICH IS WHAT CAUSED THE CONNECTION TO SEPARATE THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER 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 IS NOT AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING ASSISTANCE ENDING THERAPY ON THE HOMECHOICE(HC) DURING INITIAL DRAIN. THE HP STATED THE DRAIN VOLUME EQUALED 260ML. THE HP STATED THAT SHE BECAME DISCONNECTED FROM THE PATIENT LINE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HELPED THE HP END THERAPY. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED SHE HAD CONNECTED HER CATHETER TO THE PATIENT LINE INCORRECTLY WHICH IS WHAT CAUSED THE CONNECTION TO SEPARATE. THE HP STATED THAT AFTER CONNECTING WITH NEW SUPPLIES SHE WAS ABLE TO RESUME THERAPY WITHOUT ANY COMPLICATIONS. THE HP STATED SHE HAS ALREADY DISPOSED OF THE SUPPLIES AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE HOME PATIENT ALSO STATED NO COMPANION SAMPLES WERE AVAILABLE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 66 YR