BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCA MODULE

    MDR report key: 908617 · Received September 5, 2007

    Report

    Report Number
    2016493-2007-00041
    Event Type
    Injury
    Date Received
    September 5, 2007
    Date of Event
    May 26, 2007
    Report Date
    August 6, 2007
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    MEA
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED.

    Description of Event or Problem · 1

    REPORTED BY CUSTOMER MEDWATCH REGARDING POST OP PATIENT RECEIVING BUPIVICAINE EPIDURAL REQUIRING FREQUENT BOLUSES FOR PAIN RELIEF. LAST BOLUS AT 12:00 AM. GIVEN DILAUDID 0.4MG IV (TIME NOT DOCUMENTED) WITH SOME RELIEF, NO UNTOWARD EFFECT. AT 0230, PCA WAS STARTED, ORDER FOR 0.2MG DOSE PER PCA BY PATIENT. PATIENT IMMEDIATELY BECAME UNRESPONSIVE, RESPIRATORY RATE 6, 02 SAT. 85%. NARCAN GIVEN X 2, INCREASED 02 REQUIRED. ECG NEGATIVE. RETURNED TO BASELINE, ALERT AND ORIENTED X3, B/P OK. A PHONE CALL WAS MADE TO RISK MANAGER REQUESTING ADDITIONAL INFORMATION. SHE RESPONDED THAT ADDITIONAL INFORMATION WOULD BE PROVIDED DURING PLANNED CUSTOMER ADVOCACY VISIT SCHEDULED FOR 8/23. AS NO ADDITIONAL INFORMATION SPECIFIC TO THIS REPORT WAS AVAILABLE DURING SITE VISIT, LETTER WAS SENT TO RISK MANAGER AND ASSISTANT DIRECTOR OF BIOMEDICAL ENGINEERING REQUESTING DEVICE BE SENT IN FOR EVALUATION AND ASKING FOR ADDITIONAL INFORMATION INCLUDING EVENT SPECIFICS AND DEVICE SERIAL NUMBER. ASSISTANT DIRECTOR OF BIOMEDICAL ENGINEERING WILL WORK WITH HIS TEAM TO OBTAIN DEVICE(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PCA MODULE MEA, PCA INFUSION PUMP MEA CARDINAL HEALTH ALARIS PRODUCTS 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention