BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2103437 · Received May 26, 2011

    Report

    Report Number
    6000001-2011-04654
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A SEPARATION WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGNS OF PHYSICAL ABNORMALITY. THE LUER LOCK AND CONNECTOR WERE FOUND TO BE SECURELY CONNECTED TO EACH OTHER WITHOUT ANY EVIDENCE OF DISCONNECTION OR DEFECT. TO FURTHER VERIFY THE REPORTED CONDITION, GREEN SOLUTION WAS ADDED TO THE BLADDER THEN THE INFUSOR UNIT WAS MONITORED FOR 24 HOURS. AFTER 24 HOURS OF MONITORING, NO EVIDENCE OF DISCONNECTION OR LEAKAGE WAS OBSERVED AT THE CONNECTION OF THE INFUSOR'S LUER LOCK. THE INFUSOR AND THE CONNECTOR PERFORMED AS EXPECTED. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT ONE (1) BAXTER INFUSOR SV2 (CODE (B)(4) LOT 10M087) DISCONNECTED FROM THE IMPLANTABLE CHAMBER OF THE PATIENT. ACCORDING TO THE REPORTER, THE INFUSOR WAS CONNECTED TO THE PATIENT AT HOSPITAL FOR A 3 DAYS CHEMOTHERAPY INFUSION. THE REPORTER STATED THAT WHEN THE PATIENT WENT BACK HOME, THE NURSE OBSERVED THAT THE DISTAL LUER LOCK WAS NOT COMPLETELY FIXED TO THE PATIENT CATHETER AND DISCONNECTED. THERE ARE NO CLINICAL CONSEQUENCES OBSERVED. NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10M087

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER