BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 11731512 · Received April 27, 2021

    Report

    Report Number
    3004932373-2021-00220
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    April 15, 2021
    Report Date
    April 20, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 NEW ALLERGY TO CHLORAPREP WITH RASH AND REDNESS TO CENTRAL LINE SITE. THIS UNITED STATES CASE IS A SOLICITED REPORT RECEIVED ON (B)(6) 2021, FROM A CONSUMER VIA(B)(6). THIS (B)(6) MALE PATIENT BEGAN THERAPY WITH REMODULIN (TREPROSTINIL SODIUM, CONCENTRATION OF 5 MG/ML), ON (B)(6) 2021 FOR PRIMARY PULMONARY ARTERIAL HYPERTENSION. THE CURRENT DOSE WAS REPORTED AS 0.098 G/KG, CONTINUOUS VIA INTRAVENOUS (IV) ROUTE. ON AN UNREPORTED DATE IN (B)(6) 2021, THE PATIENT EXPERIENCED THE EVENTS OF SEVERE HEADACHES (HEADACHE), WORSE PERIPHERAL NEUROPATHY (NEUROPATHY PERIPHERAL) AND ONGOING JAW PAIN (PAIN IN JAW). CONCOMITANT MEDICATIONS INCLUDED ADEMPAS (RIOCIGUAT), XARELTO (RIVAROXABAN) AND OPSUMIT (MACITENTAN). RELEVANT MEDICAL HISTORY INCLUDED PRIMARY PULMONARY ARTERIAL HYPERTENSION AND ASCITES. ON AN UNREPORTED DATE IN (B)(6) 2021, SINCE GOING UP ON REMODULIN LAST WEEK THE PATIENT HAD SEVERE HEADACHES AND WORSE PERIPHERAL NEUROPATHY. THE PHYSICIAN WAS HOLDING REMODULIN AT 98NG/KG/MIN AND SINCE THEN HEADACHES RESOLVED AND NEUROPATHY WAS UNCHANGED. THE PATIENT HAD ONGOING JAW PAIN AND ALSO HAD ONGOING ASCITES THAT PATIENT HAD PRE-EXISTING TO REMODULIN. ACTION TAKEN WITH IV REMODULIN WAS NOT REPORTED FOR THE EVENTS OF HEADACHE, NEUROPATHY PERIPHERAL AND PAIN IN JAW. AT THE TIME OF REPORTING, THE OUTCOME OF NEUROPATHY PERIPHERAL, AND PAIN IN JAW WAS CONSIDERED AS NOT RESOLVED AND THE OUTCOME OF HEADACHE WAS CONSIDERED AS RESOLVED ON AN UNREPORTED DATE IN (B)(6) 2021. THE REPORTER'S CAUSALITY FOR THE EVENT OF HEADACHE AND NEUROPATHY PERIPHERAL WITH IV REMODULIN WAS CONSIDERED TO BE POSSIBLY RELATED. THE REPORTER DID NOT PROVIDE CAUSALITY FOR THE EVENT OF PAIN IN JAW. ADDITIONAL INFORMATION WAS RECEIVED AS SOLICITED INFORMATION ON 02 APR 2021 FROM A CONSUMER VIA (B)(6). THE EVENT OF NEUROPATHY PERIPHERAL CONSIDERED TO BE MEDICALLY SIGNIFICANT AND UPGRADED THE CASE TO SERIOUS. ON AN UNREPORTED DATE IN 2021, THE PATIENT EXPERIENCED THE EVENTS OF SEROUS DRAINAGE AROUND THE EXIT INFUSION SITE (INJECTION SITE DISCHARGE), REDNESS ABOUT THE SIZE OF THE BIOPATCH RIGHT AT THE EXIT SITE (INJECTION SITE ERYTHEMA) AND LOWER EXTREMITY EDEMA (OEDEMA PERIPHERAL). THE PATIENT WAS HAVING SEROUS DRAINAGE AROUND THE EXIT INFUSION SITE AND HAS REDNESS ABOUT THE SIZE OF THE BIOPATCH RIGHT AT THE EXIT SITE. THE PATIENT'S HEADACHES (HEADACHE PREVIOUSLY REPORTED) HAVE RESOLVED BUT CONTINUED WITH JAW PAIN (PAIN IN JAW PREVIOUSLY REPORTED). THE PATIENT ALSO HAD PERIPHERAL NEUROPATHY (NEUROPATHY PERIPHERAL PREVIOUSLY REPORTED), ASCITES, AND LOWER EXTREMITY EDEMA. ACTION TAKEN WITH IV REMODULIN WAS NOT REPORTED FOR THE EVENTS OF INJECTION SITE DISCHARGE, INJECTION SITE ERYTHEMA AND OEDEMA PERIPHERAL. AT THE TIME OF REPORTING, THE OUTCOME OF INJECTION SITE DISCHARGE, INJECTION SITE ERYTHEMA AND OEDEMA PERIPHERAL WERE UNKNOWN. THE REPORTER DID NOT PROVIDE CAUSALITY FOR THE EVENTS OF INJECTION SITE DISCHARGE, INJECTION SITE ERYTHEMA AND OEDEMA PERIPHERAL. FOLLOW-UP INFORMATION WAS RECEIVED AS SOLICITED INFORMATION ON 06 APR 2021 FROM A CONSUMER VIA (B)(6). ON AN UNREPORTED DATE IN 2021, THE PATIENT HAD NEW ALLERGY TO CHLORAPREP WITH RASH AND REDNESS TO CENTRAL LINE SITE (DERMATITIS CONTACT) AND FRACTURE TO THE RADIAL HEAD OF LEFT ARM (RADIUS FRACTURE). CO-SUSPECT MEDICATION INCLUDED: CHLORAPREP (CHLORHEXIDINE GLUCONATE, ISOPROPANOL). THE PATIENT STATED THAT HE HAD ONGOING ISSUES WITH JAW PAIN (PAIN IN JAW PREVIOUSLY REPORTED), ASCITES, PERIPHERAL NEUROPATHY AND HAD NEW ALLERGY TO CHLORAPREP WITH RASH AND REDNESS TO CENTRAL LINE SITE. THE PATIENT HAD FRACTURE TO THE RADIAL HEAD OF LEFT ARM, AND IT WAS UNKNOWN HOW FRACTURE TO HIS ARM OCCURRED. ACTION TAKEN WITH IV REMODULIN AND CHLORAPREP WAS NOT REPORTED FOR THE EVENTS OF DERMATITIS CONTACT AND RADIUS FRACTURE. ACTION TAKEN WITH CHLORAPREP WAS NOT REPORTED FOR THE EVENTS OF NEUROPATHY PERIPHERAL, HEADACHE, PAIN IN JAW, INJECTION SITE DISCHARGE, INJECTION SITE ERYTHEMA AND OEDEMA PERIPHERAL. AT THE TIME OF REPORTING, THE OUTCOME OF DERMATITIS CONTACT AND RADIUS FRACTURE WAS UNKNOWN. THE REPORTER DID NOT PROVIDE CAUSALITY FOR THE EVENTS OF RADIUS FRACTURE AND DERMATITIS CONTACT. CASE COMMENT/SENDERS COMMENT: THE COMPANY HAS ASSESSED THE SERIOUS EVENT OF NEUROPATHY PERIPHERAL AS POSSIBLY RELATED TO IV TREPROSTINIL BASED ON THE PLAUSIBLE TEMPORAL RELATIONSHIP. THE EVENT WAS LIKELY A WORSENING OF PATIENT'S UNDERLYING NEUROPATHY AS THE DOSE OF TREPROSTINIL WAS INCREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629553 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 52 YR Other