BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR SV 2, 12 PACK

    MDR report key: 1628067 · Received March 10, 2010

    Report

    Report Number
    6000001-2010-00277
    Event Type
    Malfunction
    Date Received
    March 10, 2010
    Date of Event
    February 9, 2010
    Report Date
    February 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS ACTUAL DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION; HOWEVER, A COMPANION SAMPLE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION DID NOT CONFIRM THE REPORTED CONDITION OF AN OVERINFUSION, AND NO ROOT CAUSE COULD BE DETERMINED. THIS DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. BATCH REVIEW: NO INFORMATION PERTINENT TO THE REPORTED CONDITION WAS DISCOVERED. THE LOT MET THE ACCEPTANCE CRITERIA FOR RELEASE. THE PMA/510(K) NUMBER HAS BEEN CORRECTED TO K041738.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE IS DISTRIBUTED FOR OUTSIDE OF THE UNITED STATES; THEREFORE IT DOES NOT HAVE A 510K NUMBER, HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE THIS DEVICE IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE UNITED STATES. THE DEVICE IS AVAILABLE FOR EVALUATION, PER THE CUSTOMER, HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(6) THAT A CE INFUSOR SV2 DEVICE INFUSED OVERINFUSED DURING PATIENT USE. THE DEVICE INFUSED WITHIN THE EXPECTED 48 HOURS. ACCORDING TO THE REPORTER, THE PATIENT (B)(6) WAS CONNECTED TO THE INFUSOR FOR ANALGESIC TREATMENT WITH AN OPIATE. IT IS UNKNOWN IF THERE IS PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE HEAD IS NOT CONNECTED TO THE BODY. THE HEAD OF THE STAPLER WOULDN'T FIX WITH THE TROCAR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR SV 2, 12 PACK PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 07H027

    Patients

    Seq Age Sex Outcome Treatment
    1