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

Catalog Number UNKNOWN

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problem Burning Sensation (2146)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

On 10-aug-2020, a spontaneous report was received from a consumer, via united therapeutics (manufacturer report number: (b)(4)), regarding a (b)(6) female who was being treated with chloraprep (chlorhexidine gluconate, isopropyl alcohol) and remodulin 2.5 mg/ml (treprostinil sodium).Medical history included primary pulmonary arterial hypertension.Concomitant products included ambrisentan and sildenafil citrate.On an unspecified date, the patient started treatment with chloraprep at an unreported dose and frequency of administration, applied topically for infection prophylaxis.On (b)(6) 2019, the patient started treatment with remodulin 2.5 mg/ml at an unknown dose administered continuously via iv (intravenous) drip for primary pulmonary arterial hypertension.The current dose of remodulin was reported as 0.070 mg/kg administered continuously via iv drip.On an unspecified date, after starting the products, the patient experienced a skin burn from chloraprep, also reported as a chemical burn of the skin.As of (b)(6) 2020, the outcome of the chemical burn of the skin and the actions taken with chloraprep and remodulin as a result of the event were not reported.The patient felt that the chemical burn of the skin was not related to the iv remodulin.No additional information was provided.

Manufacturer Narrative

No additional information was provided by united therapeutics.Propharma 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

On 10-aug-2020, a spontaneous report was received from a consumer, via united therapeutics (manufacturer report number: (b)(4)), regarding a 38-year-old female who was being treated with chloraprep (chlorhexidine gluconate, isopropyl alcohol) and remodulin 2.5 mg/ml (treprostinil sodium).Medical history included primary pulmonary arterial hypertension.Concomitant products included ambrisentan and sildenafil citrate.On an unspecified date, the patient started treatment with chloraprep at an unreported dose and frequency of administration, applied topically for infection prophylaxis.On 31-may-2019, the patient started treatment with remodulin 2.5 mg/ml at an unknown dose administered continuously via iv (intravenous) drip for primary pulmonary arterial hypertension.The current dose of remodulin was reported as 0.070 ¿g/kg administered continuously via iv drip.On an unspecified date, after starting the products, the patient experienced a skin burn from chloraprep, also reported as a chemical burn of the skin.As of (b)(6) 2020, the outcome of the chemical burn of the skin and the actions taken with chloraprep and remodulin as a result of the event were not reported.The patient felt that the chemical burn of the skin was not related to the iv remodulin.No additional information was provided.

• Brand Name: UNKNOWN CHLORAPREP
• 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
• MDR Report Key: 10435078
• MDR Text Key: 205337700
• Report Number: 3004932373-2020-00005
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 08/09/2020
• Supplement Dates FDA Received: 11/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 85