BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3883743 · Received February 12, 2014

    Report

    Report Number
    2016493-2014-00086
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 2, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED IN SECTIONS A AND B. THIS REPORT WAS FILED BY THE MANUFACTURER. THE CUSTOMER'S REPORT OF TWO PUMP MODULES SHUTTING OFF WITH A BLANK SCREEN WAS CONFIRMED AND REPLICATED, HOWEVER THE PUMP MODULES SHUTTING OFF WITHOUT AN ALARM WAS NOT CONFIRMED. THE LOGS SHOWED ON THE DAY OF THE EVENT FOUR PUMP MODULES WERE ATTACHED TO THE PCU. THE SOURCE DEVICE WS FOUND TO BE INFUSION NOREPINEPHRINE USING GUARDRAILS AT A CONCENTRATION OF 8MG/250ML. BEGINNING AT 8:54 AM MULTIPLE CHANNEL DISCONNECT EVENTS OCCURRED THAT WEE ALL ACKNOWLEDGED BY THE USER. THE CHANNEL DISCONNECTIONS/LOSS OF POWER EVENTS CAUSED THE ACTIVE INFUSION (ON THE LEFT SIDE) TO STOP RUNNING AND THE MODULES TO RE-INITIALIZE. THE PCU SCREEN DISPLAYED THE CHANNEL DISCONNECT MESSAGE. DURING TESTING OF THE RETURNED SYSTEM, THE SYSTEM COULD BE MANIPULATED CAUSING A LOSS OF POWER WITH A CHANNEL DISCONNECT MESSAGE ON THE PCU SCREEN. EACH TIME AN AUDIO ALARM ACCOMPANIED THE CHANNEL DISCONNECT MESSAGE. INSPECTION OF THE SOURCE PUMP MODULE CONFIRMED THAT THE MALE (RIGHT) CONNECTOR WAS FOUND TO HAVE A DAMAGED RIB BETWEEN PINS 3 AND 4. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE IS A DAMAGED PUMP MODULE MALE IUI CONNECTOR WHICH LED TO THE CHANNEL DISCONNECT/LOSS OF POWER EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN INFUSION ON AN ICU PATIENT, TWO PUMP MODULES ON THE RIGHT SIDE OF THE PCU SHUT DOWN FOUR TIMES WITHOUT AN ALARM. THIS REPORT IS FOR THE THIRD EVENT. WHILE IN RADIOLOGY THE TWO PUMP MODULES ON THE RIGHT SIDE TURNED OFF WITHOUT AN ALARM AND THE SCREENS WERE BLANK. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94262 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, (B)(4)| ALARIS PUMP MODULES, (B)(4)| MODELS/LOT NUMBER UNKNOWN| ALARIS PUMP MODULES, (B)(4)| ALARIS PUMP MODULES, (B)(4)| ALARIS PUMP MODULE ADMINISTRATION SETS,