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

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.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported that: a patient, 81 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 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.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9911633
• MDR Text Key: 185980546
• Report Number: 3006425876-2020-00287
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K962577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/30/2020
• Device Catalogue Number: CS-25854-E
• Device Lot Number: 71F18H2399
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 05/06/2020
• Supplement Dates FDA Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR