BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 11639386 · Received April 8, 2021

    Report

    Report Number
    3004932373-2021-00182
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    March 29, 2021
    Report Date
    April 9, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PR (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    MATERIAL NO.: UNKNOWN. BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THE PATIENT DEVELOPED HYPOTENSION, URTICARIA, BRONCHOSPASM, AND OTHER SYMPTOMS OF ANAPHYLAXIS SOON AFTER GENERAL ANESTHESIA AFTER APPLICATION OF CHLORHEXIDINE. PER ARTICLE ABSTRACT: IDENTIFYING THE CULPRIT MEDICATION IN CASES OF PERIOPERATIVE ANAPHYLAXIS CAN BE EXTREMELY CHALLENGING. A DETAILED AND ACCURATE HISTORY, COUPLED WITH THE APPROPRIATE TESTING, PLAYS A KEY ROLE IN DISCOVERING THE ETIOLOGY OF PERIOPERATIVE ANAPHYLAXIS. WE PRESENT THE CASE OF A [OMITTED] WITH A CRANIAL MENINGIOMA WHO WAS SCHEDULED FOR SURGERY. CHLORHEXIDINE, MIDAZOLAM, LIDOCAINE, PROPOFOL, FENTANYL, ROCURONIUM, AND FUROSEMIDE WERE ADMINISTERED DURING THE PERIOPERATIVE PERIOD. SHE DEVELOPED HYPOTENSION, URTICARIA, BRONCHOSPASM, AND OTHER SYMPTOMS OF ANAPHYLAXIS SOON AFTER GENERAL ANESTHESIA. THE SERUM TRYPTASE LEVEL OBTAINED DURING ANAPHYLAXIS WAS 119 NG/ML (NORMAL, <11.4 NG/ML). EPINEPHRINE WAS ADMINISTERED, AND THE SURGERY WAS CANCELED, WITH NO CAUSE IDENTIFIED. FOR THE NEXT SURGICAL ATTEMPT, SHE WAS PRETREATED WITH DIPHENHYDRAMINE AND RANITIDINE, AND THE NEUROMUSCULAR BLOCKER WAS WITHHELD. AGAIN, SHE DEVELOPED HYPOTENSION CONSISTENT WITH ANAPHYLAXIS, AND EPINEPHRINE WAS ADMINISTERED. SHE WAS REFERRED FOR CONSULTATION. A DETAILED AND ACCURATE HISTORY WAS OBTAINED. THE BASELINE SERUM TRYPTASE LEVEL WAS 6.4 NG/ ML. SKIN-PRICK PUNCTURE TESTS WERE COMPLETED, AND A DIAGNOSIS WAS MADE. THE SURGICAL TEAM WAS INSTRUCTED TO AVOID THE CULPRIT MEDICATION, AND THE CRANIAL SURGERY WAS SUCCESSFUL. ALTHOUGH DIFFICULT, CASES OF PERIOPERATIVE ANAPHYLAXIS CAN BE SOLVED WITH A DETAILED HISTORY, KEEN DETECTIVE WORK, AND APPROPRIATE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530267 UNKNOWN CHLORAPREP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other