BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PC UNIT

    MDR report key: 7860118 · Received September 10, 2018

    Report

    Report Number
    2016493-2018-00666
    Event Type
    Death
    Date Received
    September 10, 2018
    Date of Event
    August 6, 2018
    Report Date
    August 13, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF THE ALARM VOLUME DECREASING WAS CONFIRMED. PHYSICAL INSPECTION SHOWED THE DEVICE WAS IN FAIR CONDITION WITH THE INSTRUMENT SEAL NOT PRESENT. THE ONLY OBSERVED ANOMALIES WERE DULL IUI CONNECTORS AND A BENT DEVICE RELEASE LATCH. ANALYSIS OF THE PCU EVENT LOG SHOWS THERE WERE 3 INSTANCES OF AUDIO LEVEL CHANGES MADE ON (B)(6) 2018. AT 3:45 PM, THE USER CHANGED THE LEVEL FROM 5 TO 1. AT 6:11 PM, THE USER CHANGED THE LEVEL FROM 1 TO 5. AT 6:32 PM, THE USER CHANGED THE LEVEL FROM 5 TO 1 AND THEN BACK FROM 1 TO 5. FIVE IS THE LOUDEST SETTING AND 1 IS THE SOFTEST. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT OF THE ALARM VOLUME DECREASING WAS USER PROGRAMMING. CHANGING THE VOLUME SETTING REQUIRES SELECTION OF THE AUDIO ADJUST SOFTKEY, PLUS A SELECTION OF THE VOLUME SOFTKEY FOR EACH INDIVIDUAL LEVEL CHANGE BETWEEN A MINIMUM OF 1 AND A MAXIMUM OF 5.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PUMP INFUSING LEVOPHED WAS PREVIOUSLY SET AT A LEVEL 5 ALARM VOLUME HOWEVER AFTER A REVIEW BY THE FACILITY IT WAS NOTED TO HAVE BEEN DECREASED TO A VOLUME LEVEL OF 1. THE PATIENT REQUIRED IMMEDIATE MEDICAL ATTENTION DUE TO EITHER A RESPIRATORY OR CARDIAC ARREST. THE PATIENT EXPIRED AND THE CUSTOMER STATED THIS WAS NOT DUE TO ANY DEVICE MALFUNCTION. THE CUSTOMER IS REQUESTING A LOG REVIEW TO FIND OUT WHEN THE SOUND VOLUME CHANGE WAS MADE TO THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PUMP INFUSING LEVOPHED WAS PREVIOUSLY SET AT A LEVEL 5 ALARM VOLUME HOWEVER AFTER A REVIEW BY THE FACILITY IT WAS NOTED TO HAVE BEEN DECREASED TO A VOLUME LEVEL OF 1. THE PATIENT REQUIRED IMMEDIATE MEDICAL ATTENTION DUE TO EITHER A RESPIRATORY OR CARDIAC ARREST. THE PATIENT EXPIRED AND THE CUSTOMER STATED THIS WAS NOT DUE TO ANY DEVICE MALFUNCTION. THE CUSTOMER IS REQUESTING A LOG REVIEW TO FIND OUT WHEN THE SOUND VOLUME CHANGE WAS MADE TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701554 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION 8015 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death (3)8100,8015,(4)PRI TUBING, TD (B)(6)