BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 4455719 · Received January 19, 2015

    Report

    Report Number
    2016493-2015-00056
    Event Type
    Malfunction
    Date Received
    January 19, 2015
    Date of Event
    August 22, 2014
    Report Date
    September 11, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIVE MDRS (MFR #S 2015493-2015-00056, 57, 58, 59, 60) ARE BEING SUBMITTED FOR THIS EVENT, ONE FOR EACH OF THE SUSPECT DEVICES INVOLVED. THE REPORTED OCCURRENCE OF A COMMUNICATION ERROR WAS CONFIRMED AND DUPLICATED ON THE RETURNED INFUSION SYSTEM. IN ADDITION, LOG ANALYSIS IDENTIFIED THREE OCCURRENCES OF CHANNEL DISCONNECTS WITH THE SYSTEM DURING USE ON (B)(6) 2014. IN THE FIRST OCCURRENCE THE TWO PUMP MODULES ATTACHED TO THE RIGHT SIDE OF THE PCU (CHANNELS C AND D) EXPERIENCED A POWER INTERRUPTION THAT STOPPED THE BASIC INFUSION RUNNING ON CHANNEL C (LVP SERIAL NUMBER (B)(4)) AND THE NITROGLYCERIN INFUSION RUNNING ON CHANNEL D (LVP SERIAL NUMBER (B)(4)). THE INFUSIONS WERE RESTORED AND RESTARTED BY THE USER. THE SECOND INCIDENT OCCURRED APPROXIMATELY 5 1/2 HOURS LATER IN CHANNEL B (LVP SERIAL NUMBER (B)(4)), WHICH WAS POSITIONED DIRECTLY TO THE LEFT OF THE PC UNIT. AT THAT TIME CHANNEL A EXPERIENCED A COMMUNICATION ERROR, WITH THE MODULE CONTINUING TO INFUSE AS DESIGNED. THE LOG RECORDED THE MODULE AS HAVING BEEN REATTACHED, THE PROGRAMMING RESTORED, AND THE INFUSION RESTARTED. THE THIRD INCIDENT OCCURRED A FEW MINUTES LATER; A CHANNEL DISCONNECTED ALARM WAS RECORDED WHEN CHANNEL B, INFUSION NOREPINEPHRINE, EXPERIENCED A POWER INTERRUPTION AND CHANNELS A, C AND D EXPERIENCED A COMMUNICATION ERROR. THE USER ATTEMPTED TO RESTART THE NOREPINEPHRINE AFTER CLEARING THE ALARM STATE BUT RECEIVED ANOTHER CHANNEL DISCONNECTED ALARM AND SHUT DOWN THE ENTIRE SYSTEM. TESTING FOUND THE PRIMARY SOURCE FOR THE INCIDENTS THAT OCCURRED IN THE CHANNELS POSITIONED ON THE LEFT SIDE OF THE PCU WAS FOUND TO BE CAUSED BY BOTH THE LEFT AND THE RIGHT IUI CONNECTORS OF PUMP MODULE SN (B)(4) (CHANNEL B). WHEN THE NOTED IUI CONNECTORS WERE TEMPORARILY REPLACED, THE SYSTEM WAS FOUND TO HAVE NO REOCCURRENCE OF ANY CONTINUITY-RELATED ISSUES AT THE IUI CONNECTIONS, EVEN UNDER AGGRESSIVE PHYSICAL MANIPULATION OF THE SYSTEM. INSPECTION OF THE SOURCE IUI CONNECTORS FOUND THE PRESENCE OF CONTAMINATION/CORROSION ON PINS WHICH IS AN INDICATION THE PINS HAVE COME INTO CONTACT WITH A FLUID OTHER THAN 70% ISOPROPYL ALCOHOL. THE PROXIMATE CAUSE FOR THE CUSTOMER'S REPORTED EXPERIENCE IS ATTRIBUTED TO CONTAMINATION/CORROSION ON THE PINS OF THE IUI CONNECTORS ON THE PC UNIT AND MULTIPLE ATTACHED MODULES. THE ROOT CAUSE FOR THE PRESENCE OF CONTAMINATION/CORROSION WAS NOT DETERMINED DURING THE INVESTIGATION. THE CONDITION OF THE IUI CONNECTORS AS-RECEIVED IS AN INDICATION OF POSSIBLE IMPROVEMENT NEEDED IN THE CLEANING AND PM PRACTICES BEING PERFORMED. MANUFACTURER'S REPORT NUMBER: 2016493-2015-00056. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A PCU COMMUNICATION ERROR; THE SYSTEM CONSISTED OF A PCU WITH FOUR ATTACHED MODULES INITIALLY INFUSING NOREPINEPHRINE, EPINEPHRINE, AND NITROGLYCERINE. REPORTEDLY, WHEN THE COMM ERROR OCCURRED "ALL FUNCTIONS THEN FROZE AND THE PUMPS SHUT DOWN". THE PATIENT WAS ON AN INTRA-AORTIC BALLOON PUMP, AND WAS UNSTABLE PRIOR TO THE EVENT. A NEW PUMP AND MODULES WERE PROGRAMMED AND PUT INTO USE WITHIN FIVE MINUTES OF THE EVENT. NO PATIENT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44061 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION CORPORATION 8100 NA

    Patients

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