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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW VASCULAR UNKNOWN CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW VASCULAR UNKNOWN CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Device Embedded In Tissue or Plaque (3165)
Event Date 04/04/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Additional information requested from user facility. No additional information received at the time of this report.

 
Event Description

According to the medwatch "during liver transplant surgery, a rapid infusion iv catheter was placed in the right arm and used during a massive transfusion protocol and subsequent blood transfusions. On (b)(6), in the icu, the patient was noted to be in supraventricular tachycardia and hypotensive. Acls protocol was initiated with adenosine and calcium chloride given through the rapid infusion iv catheter was noted to have infiltrated. The line was removed. It was found that the introducer/dilator used to place the line had not been removed and was still inside the rapid infusion iv catheter". The user error has been addressed by sending out rapid infusion catheter educational information to anesthesia providers, including anesthesiologists, crnas, fellows and residents.

 
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Brand NameARROW VASCULAR UNKNOWN
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX 31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key8834670
MDR Text Key152671072
Report Number9680794-2019-00287
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER,USE
Reporter Occupation RISK MANAGER
Type of Report Initial,Followup
Report Date 07/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/28/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberVASCULAR UNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2019
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: 07/28/2019 Patient Sequence Number: 1
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