BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEPARIN LOCK FLUSH 10 USP UNITS/ML

    MDR report key: 2500172 · Received March 16, 2012

    Report

    Report Number
    MW5024688
    Event Type
    Injury
    Date Received
    March 16, 2012
    Date of Event
    February 21, 2012
    Report Date
    March 16, 2012
    Manufacturer
    APP PHARMACEUTICALS LLC
    Product Code
    NZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED ON (B)(6) 2012 FOR ELECTIVE REPAIR OF ASCENDING AORTIC ANEURYSM/AORTIC VALVE REPLACEMENT. IN PRE-OP, FOLLOWING INTUBATION, A LEFT SUBCLAVIAN MULTI MED LINE WAS PLACED BY ANESTHESIA. WITHIN 60 SECONDS AFTER FLUSHING THE CENTRAL LINE WITH HEPARIN, THE PT HAD A SEVERE ANAPHYLACTIC REACTION WITH SEVERE ANGIOEDEMA WITH DEVELOPMENT OF A DIFFUSE ERYTHEMATOUS REACTION OVER HIS ENTIRE BODY, AND SUBSEQUENT HEMODYNAMIC COLLAPSE WITH A BLOOD PRESSURE IN THE 30S. TRANSESOPHAGEAL ECHO AT THAT TIME SHOWED THE PT TO HAVE A COMPLETELY EMPTY LEFT VENTRICLE WITH NORMAL FUNCTION. THE PT WAS FLUID RESUSCITATED, IN ADDITION TO RECEIVING IV, VASOPRESSIN, EPINEPHRINE. BENADRYL, AND SOLU-MEDROL. DUE TO THE SEVERE REACTIONS, THE PT'S SURGERY WAS ABORTED AND THE PT WAS RETURNED TO THE INTENSIVE CARE UNIT, INTUBATED, AND PLACED ON A VENTILATOR. IN TOTAL, THE HOSPITALIZATION LASTED 10 DAYS FROM WHICH THE PT WAS DISCHARGED TO HOME. THE HOSPITALIZATION WAS COMPLICATED BY AN ILEUS AND PROBABLE MUCOSAL ISCHEMIA SECONDARY TO HIS ANAPHYLAXIS, (B)(6), URINARY INCONTINENCE AND RETENTION, AND AN UPPER EXTREMITY SUPERFICIAL VENOUS THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN LOCK FLUSH 10 USP UNITS/ML HEPARIN LOCK FLUSH 10 USP UNITS/ML NZW APP PHARMACEUTICALS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening