BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR TWO DAY 2ML/HR 12 PK

    MDR report key: 1800061 · Received August 16, 2010

    Report

    Report Number
    6000001-2010-02565
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 29, 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 EXAMINATION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF A LEAK. THE ROOT CAUSE WAS DETERMINED TO BE A SMALL GAP IN THE JUNCTION OF THE VOLUME INDICATOR AND THE PORT. THIS DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. BATCH REVIEW DETERMINED THAT NO NONCONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT. 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 A TWO DAY INFUSOR DEVICE WAS LEAKING DURING PATIENT USE. THE DEVICE WAS INFUSING AN UNKNOWN PATIENT WITH A SOLUTION OF 5-FLUOROURACIL AND SALINE WHEN DROPLETS WERE OBSERVED ON THE INSIDE OF THE DEVICE HOUSING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT UNDERWENT AF ATRIAL FIBRILLATION ABLATION. AT CONCLUSION OF CASE, GROUNDING PAD NOTED TO BE LIFTED AWAY FROM PATIENT. A BURN WAS SEEN UNDER THE PAD. THE PAD HAD NOT CRINKLED AND WHILE NOT AFFIXED, WAS STILL FLAT AGAINST THE PATIENT.THE CASE WAS REVIEWED BY A MULTI-DISCIPLINARY TEAM. THEY IDENTIFIED SEVERAL POTENTIAL CAUSES OF THE BURN, OF WHICH ONE WAS THAT THE PAD MAY HAVE BEEN DEFECTIVE. THE PAD WAS DISCARDED AFTER THE EVENT SO IT CANNOT BE EVALUATED.======================HEALTH PROFESSIONAL'S IMPRESSION======================HEAT NOT ADEQUATELY DISSIPATED AND BURN DEVELOPED. PATIENT IS SEDATED AND NOT ABLE TO TELL TEAM S/HE FELT A BURN. THE PAD IS COVERED BY DRAPING AND NOT ASSESSED DURING THE CASE. THE PATIENT CANNOT BE MOVED DURING THE PROCEDURE. MOVING THE PATIENT MAY CAUSE THE ARRHYTHMIA MAPPING TO BE LOST.

    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 09N064

    Patients

    Seq Age Sex Outcome Treatment
    1