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 Rash (2033)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.No additional information was provided by oegk-hanusch krankenhaus ((b)(6)).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 by the literature article author that the patient developed a rash while chlorhexidine was in use.Per article: while the rash still worsened and spread over the whole body, even to the oral and nasal mucosa (see figure 1), the patient never reported any itchiness or pain.Furthermore, the rash changed from papular to maculopapular and developed a dark red, almost violet color due to subcutaneous hemorrhage.The rash was treated with a high-dose intravenous glucocorticoid and desloratadine as well as topic therapy consisting of lauromacrogol 400 (thesit®), chlorhexidine, and betamethasone-cream (diproderm) and later tannosynt® compresses.We evaluated the rash every other day with a dermatology consultant.Five days after the rash had spread over the whole body, the patient's skin turned brownish and started to peel off.The patient did not give consent to a skin biopsy.Over the course of another 2 weeks, the rash slowly resolved.At the same time, blood counts were recovering.Thirty-five days after the induction, we re-biopsied his bone marrow to assess the treatment effect.Cytomorphology (<1% blasts), histological evaluations as well as the ngs (npm1, dntm3a negative) screening for genetic markers showed complete (molecular) remission.Due to his stable clinical condition, we deescalated the anti-infective therapy and slowly reduced the glucocorticoids before discharging the patient from the hospital.

• 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: 11870981
• MDR Text Key: 263481561
• Report Number: 3004932373-2021-00249
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• 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
• Date Manufacturer Received: 05/10/2021
• 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: 74 YR