BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF KIT F.AQUARIUS W/HF12AQUAMAX FILTER

    MDR report key: 1943288 · Received December 31, 2010

    Report

    Report Number
    1423500-2010-07491
    Event Type
    Malfunction
    Date Received
    December 31, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT. THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR AN AQUALINE SET THAT WAS FOUND TO HAVE A TEAR IN THE BLOOD PUMP SEGMENT TUBING. THE COMPLAINT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. NO CORRECTIVE/PREVENTIVE ACTION HAS BEEN DEFINED BECAUSE THEY WERE NOT ABLE TO DEFINE WHAT HAPPENED AND RELEVANT CAUSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AQUASET 12 BLOOD LINE SET WAS INVOLVED IN AN INCIDENT THAT REFERRED TO A TEAR IN THE BLOOD PUMP SECTION OF THE TUBING. AT THE TIME OF THE PROBLEM IT WAS REPORTED THAT THE SET HAD BEEN SET UP ENSURING NO TUBING WAS CAUGHT IN THE DOORS OR AROUND THE PUMP. THERE WERE NO ALARMS; A NURSE NOTICED THE LEAKAGE AND THEN THE TEAR AROUND THE BLOOD PUMP SECTION OF THE TUBING. THERE WERE NO ISSUES WITH THE MACHINE; EVERYTHING HAD BEEN WORKING WELL FOR APPROXIMATELY 24 HOURS UNTIL THE TEAR WAS FOUND. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HF KIT F.AQUARIUS W/HF12AQUAMAX FILTER SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK HAEMOTRONICS SPA N10229

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIAYLSIS MACHINE