BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2890633 · Received November 21, 2012

    Report

    Report Number
    2016493-2012-00502
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 25, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CHANNEL DISCONNECT/COMMUNICATION ERROR WAS CONFIRMED AND DUPLICATED DURING AN ON-SITE INVESTIGATION. A VISUAL INSPECTION FOUND EVIDENCE OF FLUID (BLOOD) SPILLAGE HAVING OCCURRED ON TOP OF THE SYSTEM. FUNCTIONAL TESTING AND INSPECTION PERFORMED FOUND THERE WAS CONTINUITY INTERMITTENCY OCCURRING WITH THE COMMUNICATION PINS ON THE REPORTED SOURCE EVENT PUMP MODULE AT ITS RIGHT IUI CONNECTION WITH THE LEFT SIDE OF THE PCU. THE RIGHT IUI CONNECTOR PINS ON THE PUMP MODULE HAD EVIDENCE OF CONTAMINATION/CORROSION DEVELOPING WITHIN THE CONTACT AREA OF THE PINS. THE ASSOCIATE PCU LEFT IU CONNECTOR PINS ALSO HAD EVIDENCE OF CONTAMINATION/CORROSION DEVELOPING WITHIN THE CONTACT AREA OF THE PINS. THE FACT THAT THERE WAS THE PRESENCE OF BLUISH GREEN CORROSION DEVELOPING SUGGESTS THE PINS HAD COME INTO CONTACT WITH A FLUID CONTAMINATE. THE PROXIMATE CAUSE FOR THE CUSTOMER'S REPORTED EXPERIENCE IS BEING ATTRIBUTED TO CONTAMINATED AND CORRODED PINS ON THE IUI CONNECTORS. EITHER AND/OR BOTH INTERFACING IUI CONNECTOR OF THE PUMP MODULE AND PCU COULD HAVE BEEN THE SOURCE FOR THE CONTINUITY INTERMITTENCY. THE ROOT CAUSE FOR THE PRESENCE OF CONTAMINATION AND CORROSION ON THE IUI CONNECTORS NOTED TO BE APPROX 6 MONTHS OLD IS NOT KNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED AN ALARM FOR CHANNEL DISCONNECT AFTER THE PUMP WAS BUMPED. UPON RECEIPT OF EVENT LOGS VIA EMAIL FROM THE CUSTOMER INFO WAS PROVIDED INDICATING THE MODULE HAD A COMMUNICATION ERROR SCROLLING. CHANNEL A WAS INFUSING SODIUM CHLORIDE, CHANNEL C WAS INFUSING LEVOPHED AND CHANNEL D WAS INFUSING EPINEPHRINE. INTENDED PROGRAMMING INFO NOT AVAILABLE. THERE WAS NO ADVERSE PT OUTCOME OR INJURY AND NO REPORT OF MEDICAL INTERVENTION. THE CUSTOMER DID NOT PROVIDE ANY ADD'L PT OR EVENT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE ADMIN SET, MODEL/LOT# UNK| THREE ALARIS PUMP MODULES, SNS 13697515, 13699783,| ALARIS PC UNIT, SN 13675400| 13674978