BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3143178 · Received May 24, 2013

    Report

    Report Number
    2016493-2013-00251
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 14, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES NOT RECEIVED, LOG REVIEW ONLY. THE CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW. THE EVENT LOGS AND DATA SET HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER IS REQUESTING AN EVENT LOG REVIEW. PATIENT WAS ADMITTED TO THE UNIT AT 1605 ON (B)(6) 2013. SHORTLY AFTER ARRIVING, THE PATIENT WENT INTO SUPRAVENTRICULAR TACHYCARDIA WITH A PULSE. AMIODARONE IV PUSH WAS GIVEN REVERTING THE PATIENT INTO A NORMAL SINUS RHYTHM. THE PATIENT BECAME HYPOTENSIVE AND LEVOPHED WAS REQUIRED AS PART OF THE RESUSCITATION EFFORTS. AMIODARONE, LEVOPHED, RINGER'S LACTATE AND MAGNESIUM WERE INFUSION AND AN ADEQUATE BLOOD PRESSURE AND CARDIAC RHYTHM WERE MAINTAINED. VERBAL ORDER WAS GIVEN TO INCREASE THE RINGER'S LACTATE TO 250ML/HR. APPROXIMATELY 20 MINUTES HAD PASSED WHEN IT WAS NOTED THAT THE LEVOPHED INFUSION WAS GOING AT A RATE OF 250ML/HR. THE PATIENT HAD RECEIVED AN 8MG LEVOPHED/250ML NORMAL SALINE DOSE IN UNDER AN HOUR'S TIME. TWO NURSES WERE IN THE ROOM ASSISTING WITH THE PATIENT CARE. ONE NURSE RESPONDED TO THE MD REQUEST TO INCREASE THE RINGER'S LACTATE TO 250ML/HR AND THE PUMP WAS ADJUSTED. THE QUESTION IS WHETHER OR NOT THE WRONG MODULE WAS PROGRAMMED INADVERTENTLY. THE PATIENT HAD A TROPONIN I RISE AND REQUIRED A CARDIAC ECHO DUE TO THE EVENT. NO ADDITIONAL PATIENT OR EVENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232017 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PC UNIT: SN (B)(4)| MODEL/LOT UNKNOWN| ALARIS PUMP MODULE: SN (B)(4)| 4 ALARIS PUMP MODULE ADMINISTRATION SETS: