BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR LV5, 12 PK

    MDR report key: 1840004 · Received September 21, 2010

    Report

    Report Number
    6000001-2010-03395
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED. THE REPORTED CONDITION OF A MALFORMED LUER THREAD WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A MOLDING DEFECT. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THIS DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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. PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT AN INFUSOR LV5 DEVICE HAD A MALFORMED LUER ADAPTER BEFORE PATIENT USE. THE MALFORMED LUER ADAPTER WAS OBSERVED WHEN TRYING TO ATTACH THE DEVICE TO THE PATIENT TO BEGIN AN INFUSION OF 5-FLUOROURACIL AND SALINE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER (B)(4) CUSTOMER SERVICE AND REPORTED THAT A PATIENT WAS NORMALLY PERFORMING DIALYSIS ON (B)(6) 2010 BUT DURING THE NIGHT SHE OBSERVED THAT SHE WAS WET. WHEN THE PATIENT WAS INVESTIGATING WHY SHE WAS WET, SHE DETECTED A LEAK ON THE CASSETTE LINE. THE PATIENT EXPERIENCED ABDOMINAL PAIN DURING THE WEEKEND BUT SHE DID NOT GO TO THE HOSPITAL. ON (B)(6) 2010, THE PATIENT WENT TO THE HOSPITAL WHERE IT WAS DETECTED THAT THERE WAS REALLY A LEAK ON THE CASSETTE LINE. PERITONEAL EFFLUENT WAS COLLECTED. THE EFFLUENT WAS TURBID AND HAD A POSITIVE CULTURE. THE PATIENT PRESENTED WITH PERITONITIS ONE WEEK AFTER THE LEAK WAS OBSERVED; HOWEVER, THE PATIENT RESPONDED WELL TO ANTIBIOTIC TREATMENT AND SHE HAS ALREADY RETURNED TO HER HOUSE. THE CASSETTE THAT PRESENTED THE LEAK WAS DISCARDED. THE PATIENT INDICATED THAT SHE TOOK AN ANTIBIOTIC FOR 10 DAYS AND NOW SHE IS WELL. THE PATIENT INDICATED THAT SHE OBSERVED THE LEAK BETWEEN THE CASSETTE AND THE TUBE DUE TO A CUT. THE PATIENT USED ALL THE UNITS OF THIS LOT AND SHE HAS ONLY 01 COMPANION SAMPLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR LV5, 12 PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10E022

    Patients

    Seq Age Sex Outcome Treatment
    1