BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2212673 · Received August 16, 2011

    Report

    Report Number
    1423500-2011-10745
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION, THEREFORE, THE SAMPLE WAS NOT REQUESTED AND A BATCH REVIEW WILL NOT BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) BECAUSE THE HOME PATIENT (HP) HAD A QUESTION REGARDING THE PATIENT LINE. THE HP STATED THAT WHEN SHE DISCONNECTED FROM MACHINE THIS MORNING SHE FORGOT TO CLOSE HER TRANSFER SET PRIOR TO PUTTING ON DISCONNECT CAP. SHE STATED THAT SHE HAD FLUID FLOW FROM HER TUBING. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED HOME PATIENT (HP) TO CALL THE REGISTERED NURSE (RN) TO LET THEM KNOW WHAT HAPPENED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S (HP) NURSE ON (B)(6) 2011 REGARDING THE LEAK FROM THE TRANSFER SET. THE NURSE STATED THAT THE HP HAD REPORTED THE ISSUE TO HER. THE NURSE SAID THAT THE TRANSFER SET WAS WORKING PROPERLY AND THE LEAK WAS DUE TO THE HP NOT CLOSING THE SET AFTER CAPPING OFF. THE NURSE HAD VERIFIED THAT THERE WERE NO DEFECTS ON THE SUPPLIES. PER THE NURSE, THE HP DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE NURSE STATED THAT THE HP WAS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. 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 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE