MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 CHLORAPREP UNKNOWN; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).No additional information was provided by united therapeutics.Primevigilance did reach out to obtain more information with no success.Should additional information be available in the future, the complaint will be re-opened and investigated.All complaints are reviewed during monthly quality/safety meetings.In addition, complaints are trended at monthly quality data analyst meetings and quarterly plant management review meetings.

Event Description

It was reported that the patient experienced a rash and burn where chloraprep was used.Per medwatch: this (b)(6) case is a solicited report received on (b)(6) 2021, from a consumer via accredo specialty pharmacy.This [omitted] patient began therapy with remodulin (treprostinil sodium, concentration 2.5 mg/ml), on (b)(6) 2020 for primary pulmonary arterial hypertension.The current dose was reported as 0.04 ¿g/kg, continuous via intravenous (iv) route.On an unreported date, the patient experienced the event of rash and burn where she uses chlorapreps (dermatitis contact).Co-suspect medication included chlorapreps (chlorhexidine continued in additional info section.Gluconate, isopropanol).Concomitant medications included opsumit (macitentan), sildenafil citrate and warfarin.Relevant medical history included primary pulmonary arterial hypertension.The patient reported that patient had rash and burn where she used chlorapreps.Action taken with iv remodulin and chlorapreps was not reported for the event of dermatitis contact.At the time of reporting, the outcome of dermatitis contact was unknown.The reporter did not provide causality for the event of dermatitis contact.

• Brand Name: CHLORAPREP UNKNOWN
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 11708982
• MDR Text Key: 255399251
• Report Number: 3004932373-2021-00210
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 77