BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAPANESE SV 2.5 INFUSOR

    MDR report key: 1771031 · Received July 27, 2010

    Report

    Report Number
    6000001-2010-01972
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 9, 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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. THE REPORTED CONDITION OF AN UNDERINFUSION WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. BATCH REVIEW DETERMINED THAT NO NONCONFORMANCE REPORTS WERE OPENED DURING MANUFACTURING OF THIS DEVICE. THIS DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT AN INFUSOR SV2.5 WAS LEAKING DURING PATIENT USE. THE DEVICE WAS INFUSING AN UNKNOWN PATIENT WITH A SOLUTION OF 5-FLOUROURACIL AND SALINE WHEN THE INFUSION STOPPED. WHEN THE DEVICE WAS FORCE PRIMED IN AN ATTEMPT TO CONTINUE THE INFUSION, THE DEVICE BEGAN LEAKING FROM THE LUER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    ABBOTT CELL-DYN 3200 ANALYZER IS A MULTI-PARAMETER, AUTOMATED HEMATOLOGY ANALYZER DESIGNED FOR IN VITRO DIAGNOSTIC USE IN CLINICAL LABORATORIES. THE CELL-DYN 3200 ANALYZER HAS A FUSE LOCATED IN THE POWER SUPPLY UNIT ABOVE THE POWER CORD CONNECTOR ON THE REAR PANEL. THE FUSE IS AN ESSENTIAL PART OF THE POWER DISTRIBUTION SYSTEM AND PROTECTS THE ANALYZER AND COMPONENTS FROM DAMAGE. PER THE EXISTING LABELING, THE FUSE SHOULD BE REPLACED AS FOLLOWS: FOR 100/120 VOLTS: CUSTOMERS USE ONLY AN 8-AMP T (SLOW-BLOW) FUSE. FOR 220/240 VOLTS: CUSTOMERS USE ONLY A 4-AMP T (SLOW-BLOW) FUSE. CUSTOMERS HAVE REPORTED OCCURRENCES WHERE POWER SUPPLY UNITS HAVE BEEN RETURNED FOR INVESTIGATION WITH THE INCORRECT FUSE FOR THE OPERATIONAL VOLTAGE ON A SIMILAR CELL-DYN ANALYZER. UTILIZING A FUSE THAT DOES NOT MATCH THE VOLTAGE OF OPERATION MAY LEAD TO THE ANALYZER OR COMPONENT DAMAGE, SMOKE AND /OR FIRE. WHEN PRODUCTS ARE USED IN ACCORDANCE WITH THE CURRENT LABELING, THERE IS NO IMPACT TO PRODUCT FUNCTIONALITY OR PERFORMANCE, PATIENT RESULTS OR USER SAFETY. A PRODUCT CORRECTION LETTER HAS BEEN ISSUED AND REPORTED UNDER 21CFR806 FOR THE CELL-DYN/ANALYZER TO THE (B)(4) ON (B)(4) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAPANESE SV 2.5 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1