BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 20404779 · Received October 9, 2024

    Report

    Report Number
    2016493-2024-38343
    Event Type
    Malfunction
    Date Received
    October 9, 2024
    Date of Event
    September 17, 2024
    Report Date
    November 12, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    MEA
    UDI-DI
    10885403812033
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    CORRECTION: DESCRIBE EVENT OR PROBLEM ADDITIONAL INFORMATION: IMDRF ANNEX B CODE AND MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED ISSUE OF AN PCA OVER INFUSION / DOSE DELIVERED WITHOUT REQUEST WAS NOT DETERMINED BECAUSE NO PRODUCTS OR DEVICE LOGS WERE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PCA HISTORY SHOWS THERE WERE ZERO ATTEMPTS MADE, ZERO DELIVERED WHEN REGISTERED NURSE (RN) VERIFYING THE IV INFUSIONS. HOWEVER WHEN SHE WENT TO VOLUME INFUSED FOR EACH MODULE, THE VOLUME FOR THE PCA WAS 13ML. SHE CLEARED THE PCA PUMP HOWEVER SHE DID NOT DOCUMENT THAT VOLUME AS THE PATIENT STATED THAT SHE DID NOT PRESS THE PCA DOSE REQUEST CORD. SHE REPORTED THAT THE PATIENT IS ON A PCA DOSE ONLY AND SAID PATIENT IS ALERT AND ORIENTED X4 AND AN ACCURATE HISTORIAN. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT CONTROLLED ANALGESIA (PCA) PUMP DELIVERED MEDICATION WHEN NO REQUEST WAS MADE. WHEN THE CLINICIAN WENT TO VOLUME INFUSED FOR EACH MODULE, THE VOLUME FOR THE PCA DELIVERED WAS 13ML. THE CLINICIAN CLEARED THE PUMP. THE PATIENT INDICATED THEY DID NOT REQUEST A DOSE. THE CLINICIAN ASSESSED THE PATIENT WAS "ALERT AND ORIENTED X4 AND AN ACCURATE HISTORIAN." THERE WAS PATIENT INVOLVEMENT, BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745152 ALARIS SYSTEM PUMP, INFUSION MEA CAREFUSION SD 8120 10885403812033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015