BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLSA DE EVA 2000ML

    MDR report key: 1901815 · Received November 17, 2010

    Report

    Report Number
    6000001-2010-04951
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - SAO PAULO
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES 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). AN ACTUAL SAMPLE WAS NOT AVAILABLE; HOWEVER, A COMPANION SAMPLE WAS SUBMITTED FOR EVALUATION AND IS REFERENCED UNDER MDR 6000001-2010-04944. A VISUAL EXAMINATION OF THE SAMPLE CONFIRMED THE REPORTED CONDITION OF A LEAK. THE ROOT CAUSE OF THIS CONDITION WAS DETERMINED TO HAVE BEEN CAUSED BY A TEAR ON THE PERIPHERY OF THE BAG DUE TO A WEAK SEAL RESULTING FROM A LACK OF POWER ON THE RADIO FREQUENCY SEALER. MANUFACTURING HAS MADE A REVISION OF THE MATRIX OF SEALING (CONFERENCE DIMENSIONAL) EXCHANGE OF CONTACTS OF THE CONTACTOR GENERATOR RF (RADIO FREQUENCY) AND THE EXCHANGE OF CONTACTS OF THE CONNECTOR VALVE RF. BAXTER WILL CONTINUE TO MONITOR THE TREND FOR THIS TYPE OF OCCURRENCE AND THE NEED FOR ADDITIONAL ACTIONS. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS IS REPORT 2 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED TO BAXTER (B)(4) AN EMPTY ALL-IN-ONE EVA CONTAINER (2000ML) THAT HAD A LEAK. THE CONDITION OCCURRED DURING INFUSION ON A PATIENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THIS IS REPORT 2 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOLSA DE EVA 2000ML CONTAINER, I.V. KPE BAXTER HEALTHCARE - SAO PAULO PE27P6

    Patients

    Seq Age Sex Outcome Treatment
    1