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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number CV-12142-UF
Device Problem Product Quality Problem (1506)
Patient Problems Air Embolism (1697); No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Additional information received: about the gas embolism, the customer discovered the gas embolism and noticed the catheter was not clamped. So, they don't know if it was a device failure or a medical error (they could have forgotten to clamp). The facility solved the issue immediate and took care of the patient. It is reported that the patient is fine. The customer said it was difficult to clamp with teleflex devices but in the other hand the sales representative performed a demo of the clamp to show them how to do it. They are going to do a fresh training to the staff in september.

 
Event Description

The customer reports: recently, during an analyses on the patient after a gas embolism during a plasma exchange session in the context of an acute humoral rejection of a pulmonary graft, we had a difficulty to clamp the dialysis catheter.

 
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Brand NameARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM
Type of DeviceCATHETER, PERCUTANEOUS
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 Key10245345
MDR Text Key197960771
Report Number3006425876-2020-00616
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberCV-12142-UF
Device LOT Number71F19L1361
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 Received08/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/19/2019
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: 07/08/2020 Patient Sequence Number: 1
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