ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT: 9 FR DISTAL X 4-1/2 CATHETER, INTRAVASCULAR
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Catalog Number ASK-21242-NYP |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
No Consequences Or Impact To Patient (2199); Reaction (2414)
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Event Date 01/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
The results of the investigation are incomplete at the time of this report.
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Event Description
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The customer alleges that the patient was induced under general anesthesia and successfully trached.
Drugs given were: midazolam, fentanyl, propofol, and rocuronium.
The patient was then stable.
Approx 15-20 min later the patient was prepped for introducer insertion (9fr.
Mac placed).
Insertion went smoothly.
Hr went from 60-90, b/p fell - map into 40's.
Head was red and flush.
Physician paused then removed catheter.
Prior to removal, vaso pressor given with no effect.
Through piv several doses of epinephrine were administered.
Patient stabilized in 10-15 mins.
Procedure cancelled.
Allergist saw patient and will be testing for chlorhexidine and sulfur allergy.
The patient's condition is reported as fine.
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Manufacturer Narrative
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Qn#(b)(4).
The sample was not returned for evaluation.
The lot number was not reported; therefore, the device history record (dhr) review was performed based on sales history of the customer.
There were no relevant findings.
The ifu for this product states this catheter is contraindicated for patients with a known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs.
It also warns that hypersensitivity reactions are a concern with antimicrobial catheters in that they can be very serious and even life-threatening.
Complaint verification testing could not be performed as no sample was returned for analysis.
A dhr review did not reveal any manufacturing related issues.
The probable cause of the patient experiencing an allergic reaction after the sheath insertion could not be determined based on the information provided and without a sample.
If the sample is returned, a follow-up report will be submitted with investigation results.
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Event Description
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The customer alleges that the patient was induced under general anesthesia and successfully trached.
Drugs given were: midazolam, fentanyl, propofol, and recuronium.
The patient was then stable.
At 15-20 min later, the patient was prepped for introducer insertion (9fr.
Mac placed).
Insertion went smoothly.
Hr went from 60-90, b/p fell - map into 40's.
Head was red and flush.
Physician paused then removed catheter.
Prior to removal, vaso pressor given with no effect.
Through piv several doses of epinephrine were administered.
Patient stabilized in 10-15 mins.
Procedure cancelled.
Allergist saw patient and will be testing for chlorhexidine and sulfur allergy.
The patient's condition is reported as fine.
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Search Alerts/Recalls
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