BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLINK CONTINU-FLO, 3 INJECTION SITES, LUER LOCK, 105"

    MDR report key: 1943216 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06519
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BAXTER HEALTHCARE - SHERBROOKE
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, AN MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADDITIONAL EVENT DETAILS ARE AVAILABLE. SINCE THE SAMPLE WAS NOT PROVIDED, THE COMPLAINT COULD NOT BE CONFIRMED. THE DESCRIPTION OF THIS COMPLAINT APPEARS TO POINT TO PRIMING DIFFICULTIES. PRIMING DIFFICULTIES IS OFTEN RELATED TO A HIGH CRACKING PRESSURE OF THE NP CHECK VALVE. THEREFORE, THE ROOT CAUSE WAS DETERMINED TO BE HARD CRACKING PRESSURE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH CAPA INVESTIGATION (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERLINK SET THAT HAD A NO FLOW. THIS REPORTED CONDITION OCCURRED DURING PATIENT-USE. CHEMOTHERAPY WAS SUPPOSED TO BE INFUSED; HOWEVER, WITH THE NO-FLOW, IT DID NOT INFUSE. THERE WAS NO PATIENT INJURY; HOWEVER, THE PATIENT'S CENTRAL LINE BECAME OCCLUDED AND REQUIRED THE USAGE OF TISSUE PLASMINOGEN ACTIVATOR. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 5 OF 6 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK CONTINU-FLO, 3 INJECTION SITES, LUER LOCK, 105" SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SHERBROOKE ST10E017

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CHEMOTHERAPY