BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3043419 · Received March 13, 2013

    Report

    Report Number
    2016493-2013-00141
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 8, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF CHANNEL DISCONNECT EVENT HAS BEEN CONFIRMED AND DUPLICATED. A REVIEW OF THE DEVICE LOGS FOUND THE PUMP MODULE RESPONSIBLE FOR THE INFUSION OF NORMAL SALINE WAS THE PUMP MODULE WITH THE UNIT LABELING AS CHANNEL C AND NOT CHANNEL D ((B)(4)) AS REPORTED. THE CHANNEL C MODULE WAS ALSO NOT THE FIRST PUMP TO ALARM FOR A DISCONNECT EVENT. PER THE LOG, CHANNEL D ALARMED FIRST. DURING THE PT INCIDENT, THERE WAS NO INDICATION THE INFUSION STOPPED AS A RESULT OF THE CHANNEL DISCONNECT. THE PUMP MODULES ALARMED FOR A COMMUNICATION ERROR AFTER THE CHANNEL DISCONNECT EVENT, WHICH BY DESIGN MEANS THEIR INFUSIONS WERE CONTINUING AS LAST PROGRAMMED WITHOUT HAVING THE ABILITY TO MAKE CHANGES TO THE INFUSION PARAMETERS. TESTING AND INSPECTION FOUND THERE WERE CONNECTIVITY ISSUES OCCURRING BETWEEN THE INTERFACED IUI CONNECTORS WITH DEVICE MANIPULATIONS. THE IUI CONNECTORS HAVE PHYSICAL EVIDENCE OF CONTAMINATION/CORROSION PRESENT ON PINS, WHICH IS AN INDICATION THE CONNECTORS CAME IN CONTACT WITH FLUID OTHER THAN 70% ISOPROPYL ALCOHOL. THE CAUSE FOR THE CUSTOMER'S REPORTED EXPERIENCE IS BEING ATTRIBUTED TO CONTAMINATED AND CORRODED PINS ON THE IUI CONNECTORS. THE ROOT CAUSE FOR THE PRESENCE OF CONTAMINATION AND CORROSION ON THE IUI CONNECTORS IS NOT KNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO MODULES STOPPED INFUSING DURING AN INFUSION. MODULE C (SN (B)(4)) WAS INFUSING MILRINONE AT 0.375 MCG/KG/MIN AND MODULE D (SN (B)(4)) WAS INFUSING NORMAL SALINE. MODULE C WAS THE FIRST TO START ALARMING DISCONNECTED. THEN MODULE D ALARMED DISCONNECTED. BOTH MEDICATIONS WERE IMMEDIATELY CHANGED TO TWO MODULES ADDED ON TO THE OTHER OPPOSITE SIDE OF THE PC UNIT. THE CLINICAL ENGINEER STATED THE IUI CONNECTORS DO NOT APPEAR TO HAVE CONTAMINATION OR CORROSION. THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION WAS REPORTED. ALTHOUGH REQUESTED, NO ADD'L PT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106198 ALARIS PUMP MODULE FRN CAREFUSION CORP. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SNS (B)(4), (B)(4), (B)(4)| ALARIS PC UNIT, SN (B)(4)| MODEL/LOT UNKNOWN| 4 ALARIS PUMP MODULE ADMINISTRATION SETS,| ALARIS PUMP MODULES,