BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR TWO DAY 2ML/HR 12 PK

    MDR report key: 2021699 · Received March 17, 2011

    Report

    Report Number
    6000001-2011-01928
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 28, 2011
    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). ADDITIONAL NARRATIVE: THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: BAXTER RECEIVED ONE DEVICE FOR EVALUATION. REPORTED COMPLAINT FOR LEAK WAS NOT CONFIRMED. ONE UNIT WAS RECEIVED CONTAINING NO FLUID IN THE RESERVOIR. VISUAL EXAMINATION OF THE INFUSOR AND THE HUBER NEEDLE FOUND NO SIGNS OF DEFECT. A LEAK TEST WAS SUBSEQUENTLY PERFORMED BY FILLING THE RESERVOIR WITH GREEN WATER. AFTER FILL, NO EVIDENCE OF LEAK WAS NOTED AT THE CONNECTION BETWEEN THE INFUSOR'S LUER AND THE HUBER NEEDLE. THEREAFTER, THE SAMPLE WAS BEING MONITORED FOR 24 HOURS FOR ANY SIGNS OF LEAK; HOWEVER, NO SIGNS OF LEAK WERE FOUND. A BATCH REVIEW WAS CONDUCTED WHICH FOUND NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) INFUSOR TWO DAY DEVICE WAS OBSERVED LEAKING DURING PATIENT USE AT THE PATIENT'S HOME FROM THE CONNECTION SITE OF THE LUER ADAPTOR AND A HUBER NEEDLE. THE HUBER NEEDLE WAS SENT TO (B)(4). FOR INVESTIGATION. THE DEVICE WAS FILLED WITH 5-FLUOROURACIL AND NORMAL SALINE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY AND MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR TWO DAY 2ML/HR 12 PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10H067

    Patients

    Seq Age Sex Outcome Treatment
    1 5-FLUOROURACIL| NORMAL SALINE| HUBER NEEDLE