BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2964159 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03973
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K964850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:BAXTER DID NOT RECEIVE THE ACTUAL SAMPLE, HOWEVER A COMPANION SAMPLE WAS RECEIVED FOR EVALUATION. THE REPORTED CONDITION OF A LEAK COULD NOT BE CONFIRMED. A VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGNS OF PHYSICAL DEFECT. FUNCTIONAL TESTING WAS ALSO PERFORMED ON THE DEVICE, WITH NO SIGNS OF LEAKAGE DETECTED DURING TESTING. THEREFORE NO CAUSE COULD BE IDENTIFIED. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. A COMPANION SAMPLE WAS RECEIVED FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION OR IF RELEVANT ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE ONE (1) INTERLINK CONTINU-FLO SOLUTION SET IN WHICH LEAKAGE OF UNSPECIFIED CHEMOTHERAPY DRUG RESULTED WHEN THE INTERLINK PORT NEAREST THE SPIKE TUBE DISCONNECTED FROM A SECONDARY MEDICATION SET WITH INTERLINK LEVER LOCK CANNULA ON AN UNKNOWN DATE. THE CUSTOMER OBSERVED THAT THE INTERLINK SEPTUM WAS DIFFICULT TO ACCESS WITH THE CANNULA OF THE SECONDARY SET PRIOR TO THE EVENT. THERE IS PATIENT INVOLVEMENT; HOWEVER, THERE IS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68179 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R12H03045

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN CHEMOTHERAPY DRUG| SECONDARY MEDICATION SET (B)(4)