BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUALINE

    MDR report key: 2024148 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03408
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 3, 2011
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE SAMPLE BY BAXTER FOUND THAT THERE WAS BLACK RESIDUE IN THE DRIP CHAMBER, THUS CONFIRMING THE COMPLAINT. AFTER THE DISINFECTION PROCEDURE, THE RESIDUE REMAINED IN THE CHAMBER, ALTHOUGH IT TURNED BROWN. BECAUSE THE SAMPLE WAS CONSIDERED TO BE CONTAMINATED, IT COULD NOT BE SENT TO HAEMOTRONIC FOR FURTHER EVALUATION. SINCE HAEMOTRONIC COULD NOT EVALUATE THE SAMPLE, NO ROOT CAUSE COULD BE CONCLUSIVELY DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE SAMPLE HAS BEEN RECEIVED AND IS CURRENTLY BEING EVALUATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) THAT DURING PREFILLING, THERE WAS BLACK FOREIGN MATERIAL IN THE DRIP CHAMBER. THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUALINE SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK HAEMOTRONICS SPA N08311

    Patients

    Seq Age Sex Outcome Treatment
    1