MAUDE Adverse Event Report: CAREFUSION, INC 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 Reaction (2414)

Event Date 12/30/2020

Event Type  Injury  

Manufacturer Narrative

(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.Prime vigilance did reach out to obtain 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

Material no: unknown batch no: unknown.It was reported that the patient experienced the event of itching at central line site after skin is cleaned with chloraprep swab during weekly dressing change (injection site pruritus).Event description per attached email states: case description:this united states case is a solicited report received on 23 nov 2020 from consumer spouse via accredo specialty pharmacy.This (b)(6), female patient began therapy with remodulin (treprostinil sodium, concentration 1 mg/ml), on (b)(6) 2020 for secondary pulmonary arterial hypertension.The current dose was reported as 0.020 g/kg, continuous via intravenous (iv) route.On an unreported date in 2020, the patient experienced the event of itching at central line site after skin is cleaned with chloraprep swab during weekly dressing change (injection site pruritus).Co-suspect medication included chloraprep (chlorhexidine gluconate and isopropanol) via topical route.Relevant medical history included secondary pulmonary arterial hypertension.It was reported that the patient had itching at central line site after skin was cleaned with chloraprep swab during weekly dressing change.Action taken with iv remodulin and topical chloraprep was not reported for the event of injection site pruritus.At the time of reporting, the outcome of injection site pruritus was unknown.The reporter did not provide causality for the event of injection site pruritus.Additional spontaneous information was received from a consumer via accredo specialty pharmacy on 21 dec 2020.Additional information was received as solicited information on 22 dec 2020 from a consumer via accredo specialty pharmacy, upgrading the case to serious.On an unreported date in 2020, the patient experienced the events of allergic to chlorhexidine wipes- red and itching (drug hypersensitivity, medically significant), thinning of hair; hair thinning; a lot of hair falling out (alopecia), knees swelling and hurt (joint swelling and arthralgia), limping (gait disturbance), scleroderma (scleroderma), hands have sores (pain in extremity), cannot digest fresh fruits and veggies (dyspepsia), cannot tolerate cold (temperature intolerance), and trouble swallowing and cannot swallow big tablets (dysphagia).On an unreported date in (b)(6) 2020, the patient experienced the event of redness and itching under remodulin central line dressing (dermatitis contact).Additional dosage regimen of 0.022 g/kg, continuous via intravenous (iv) route, started on an unreported date in 2020, was added to iv remodulin.It was reported that the patient had redness and itching under remodulin central line dressing over past month (in (b)(6) 2020).The patient also reported thinning of hair since has been on remodulin and a lot of hair was falling out.Her knees were swelling and hurting.The patient also had limping, scleroderma, and sores on hands.Patient was unable to digest fresh fruits and veggies.The patient was not able to tolerate cold.The patient was allergic to chlorhexidine wipes, her skin was red and had itching for 6 days.The physician took off most of her supplements.The patient had trouble in swallowing and cannot swallow big tablet.Action taken with iv remodulin, topical chloraprep was not reported for the events of drug hypersensitivity, alopecia, joint swelling, arthralgia, gait disturbance, scleroderma, pain in extremity, dyspepsia, temperature intolerance, dysphagia and dermatitis contact.At the time of reporting, the outcome of drug hypersensitivity, alopecia, joint swelling,arthralgia, gait disturbance, scleroderma, pain in extremity, dyspepsia, temperature intolerance, dysphagia and dermatitis contact was unknown.The reporter assessed the causal relationship between the iv remodulin and the event of drug hypersensitivity as not related.The reporter assessed the causal relationship between the iv remodulin and the event of alopecia as possible.The reporter did not provide causality for the events of joint swelling, arthralgia, gait disturbance, scleroderma, pain in extremity, dyspepsia, temperature intolerance, dysphagia and dermatitis contact.Case comment/senders comment:the company has assessed the serious adverse event of drug hypersensitivity as not related to iv treprostinil.The event was related to chlorhexidine wipes.

• Brand Name: CHLORAPREP UNKNOWN
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• 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: 11152840
• MDR Text Key: 226601829
• Report Number: 3004932373-2020-00176
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/31/2020

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: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/11/2021
• 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: 73 YR
• Patient Weight: 48