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 11/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).No additional information was provided by triad cardiac & thoracic surgery.Primevigilance 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 3 patients experienced anaphylactic shock while using chloraprep.Per email: i wanted to send and document the information i just heard today up the ladder as soon as possible.Today i spoke to [omitted].In our conversation he mentioned he believes he had about 3 patients go into anaphylactic shock in which he believes may be because of using chloraprep.He mentioned that he has already submitted this to the fda.I told him that i would look into this and run it up the ladder internally with bd and someone would probably reach out to him regarding this issue.I had a discussion with dr (b)(6) today about his contacting the company and questions surrounding anaphylaxis.Dr (b)(6) was contacting us to make sure that we were aware of his 3 notifications of anaphylaxis to the fda approximately 18 to 24 months ago.He had 3 patients while having central venous catheters and swan ganz catheters placed in the or holding room experience immediate flushing (he thought they were pushing vanco to fast) and difficulty with breathing.He stated that he felt that the anesthesiology team was being "sloppy" and not allowing the chlorhexidine product dry prior to placement of central venous lines.He had a training session with the or team and anesthesiologists and reiterated that all antiseptics should be allowed to dry prior to placement and that the or staff should be aware of possible anaphylactic symptoms.He has not experience anaphylaxis since his training.Why he called  a patient in his holding area had a big sign that stated not to use any chg products due to hypersensitivity and/or anaphylaxis&he was reminded of the case and wanted the company to be aware of his notifications to the fda.Information that we (both dr (b)(6) and myself) have committed to research dr (b)(6) is checking on the type of cvc lines placed&he did not think they were the silver sulfadiaxine/chg coated, but he did state they are blue, i told him if they were blue and arrowgard they were the antimicrobial catheters.He is to verify dr (b)(6) did mention that chg is used everywhere in the hospital and it concerned him.Dr (b)(6) was not aware that (b)(6) had a preservative level of chg, but has had patients with allergic reaction during urinary catheter placement.Dr (b)(6) declined additional training or inservicing for his staff, since his seemed to alleviate the problem.(b)(6) will provide dr (b)(6) with a literature review on chg and anaphylaxis.(b)(6) to provide dr (b)(6) with a review article on antiseptic stewardship.(b)(6) will follow-up with dr (b)(6) as to our company data base having the 3 ade notification to fda.What is needed from pv/qppv.Data base search for all anaphylaxis cases since 2016.If data could be organized by region/state (dr (b)(6) is in (b)(6)) but it would be nice to see all anaphylaxis cases since 2016.In the meantime, dr (b)(6) is pulling his records in regards to the notification of the 3 cases to the fda from 18 to 24 months ago.Once we have determined if cases are in database or not, qppv to follow-up.(b)(6), please feel free to correct or contribute to this email.

• 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: 10939414
• MDR Text Key: 219346946
• Report Number: 3004932373-2020-00143
• 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: company representative,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/02/2020

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: 11/20/2020
• Initial Date FDA Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other