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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-25854-E
Device Problem Insufficient Information (3190)
Patient Problems Low Blood Pressure/ Hypotension (1914); Reaction (2414); Bronchospasm (2598)
Event Date 02/15/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: a patient, (b)(6) years of age, with a bowel obstruction was scheduled for surgery. She had a central line placed. Around 20 minutes into the procedure while under general anesthesia she developed bronchospasm and hypotension. She was stabilized and the procedure continued. Troubleshooting steps followed and it was suspected she had reacted to the chlorhexidine in the central line. This was removed. She had an elevated mast cell tryptase level post op, 21. 3, normal upper limit 11. She went to icu, though she had major surgery. She had a difficult post op recovery, mostly related to her age and the extent of the surgery rather than the reaction.
 
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Brand NameARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key9911633
MDR Text Key185980546
Report Number3006425876-2020-00287
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K962577
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/30/2020
Device Catalogue NumberCS-25854-E
Device Lot Number71F18H2399
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/05/2018
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: 04/01/2020 Patient Sequence Number: 1
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