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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6" CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6" CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number ASK-42703-PVCC
Device Problem Biocompatibility (2886)
Patient Problem Anaphylactic Shock (1703)
Event Date 07/28/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: ine, rocuronium. Qn# (b)(4).
 
Event Description
Patient is a (b)(6) year old male who presented for elective mitral valve repair, tricuspid repair and left atrial appendage excision. Patient received cefazolin, sufentanil, midazolam, propofol, lidocaine, rocuronium, and chlorhexidine impregnated central line. Within 30 minutes of induction, patient developed refractory hypotension and peri-arrest situation. Treatment included 3 l1 of iv fluid, initially received a bolus of norepinephrine and was maintained on an epi infusion. Later changed to chlorhexidine free cvc. Intraoperative tryptase level was 22 which remained positive 6 hours later at 22 which likely was due to "renal failure and impair repaired clearance". Patient had no prior known drug allergies. Patient underwent allergy testing and was confirmed to have a chlorhexidine allergy with skin prick testing to chlorhexidine 2% strong positive at 10x2 mm with underlying erythema and intradermal chlorhexidine 0. 002mg/ml at 10mm with underlying erythema. Patient tested negative to cefazolin, cisastracurium, rocuronium, suxamethonium, propofol, midazolam, and fentanyl. Patient's anaphylaxis was most likely caused by the chlorhexidine on the central line. Patient condition reported to be fine.
 
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Brand NameARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6"
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key12600636
MDR Text Key279539852
Report Number9680794-2021-00497
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberASK-42703-PVCC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2021
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: 10/08/2021 Patient Sequence Number: 1
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