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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW CVC KIT CATHETER INTRAVASCULAR THERAPE

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ARROW CVC KIT CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problem Biocompatibility (2886)
Patient Problem Anaphylactic Shock (1703)
Event Date 01/15/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: yl, atg, hydromorphone, dexmedetomidine. (b)(4).
 
Event Description
Through a review of records the customer reports a suspected allergic reaction to an arrow catheter. The following is reported: in (b)(6) 2020, patient presented for a deceased-donor renal transplant for end-stage renal disease of unclear etiology. Intraoperatively, patient experienced profound hypotension with a blood pressure of 60/30 approximately 40 minutes post induction, where she required boluses of epinephrine totalling 1 mg and was given iv methylprednisolone. She was also documented to have swollen tongue postop. There was also biochemical evidence of elevated tryptase at 78. 4 mcg/l which trended down on repeat at 64. 25. Intraoperatively, she received cefazolin, rocuronium, propofol, lidocaine, fentanyl, atg, hydromorphone, dexmedetomidine, and she also received a central line as well as had skin sterilization with chlorhexidine. Intradermal skin testing was performed and was strongly (b)(6) to cisatracurium at 1:100 dilution, measuring a wheel size of 10 mm with underlying erythema. Chlorhexidine prick test was (b)(6) at 3 mm with underlying erythema, and chlorhexidine intradermal was (b)(6) at 5 mm with underlying erythema. Patient was (b)(6) for cefazolin, rocuronium, suxamethonium, fentanyl, latex, and propofol. It was reported the patient had experienced perioperative anaphylaxis. The most likely causative agent was chlorhexidine from her cleaning, as well as her central line. Patient condition reported to be fine. Patient advised to avoid chlorhexidine in future.
 
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Brand NameARROW CVC KIT
Type of DeviceCATHETER INTRAVASCULAR THERAPE
MDR Report Key12578363
MDR Text Key274796170
Report Number9680794-2021-00500
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberVASCULAR UNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/05/2021 Patient Sequence Number: 1
Treatment
CEFAZOLIN, ROCURONIUM, PROPOFOL, LIDOCAINE, FENTAN
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