MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15232-VFE

Device Problems Fluid/Blood Leak (1250); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reports "the retrograde catheter has issue of sucking the air during dialysis".Catheter was found sucking air from the arterial lumen on day 2 of line inserted.The catheter was leaking when flushed with syringe and there was a backflow of blood in the arterial lumen.Therapy was delayed as patient was not able to continue the treatment on blood pump rate of more than 150ml/min.The catheter was replaced and no further issue was noted.There was no patient harm due to the machine safety mechanism.Patient "was feeling fine" and reported to be "stable outpatient".

Event Description

Customer reports "the retrograde catheter has issue of sucking the air during dialysis".Catheter was found sucking air from the arterial lumen on day 2 of line inserted.The catheter was leaking when flushed with syringe and there was a backflow of blood in the arterial lumen.Therapy was delayed as patient was not able to continue the treatment on blood pump rate of more than 150ml/min.The catheter was replaced and no further issue was noted.There was no patient harm due to the machine safety mechanism.Patient "was feeling fine" and reported to be "stable outpatient".

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided one photo and one video for analysis.The complaint of a catheter leak during use was able to be confirmed by the photo and video.The photo displayed backflow blood in the arterial line.The video revealed the arterial line had air bubbles traveling through non-arrow extension tubing that was connected to the arterial luer hub.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, with three relevant findings identified.Without the actual device returned it could not be confirmed if the failure mode of this complaint matches the failure mode of the non-conformances identified.The instructions for use (ifu) provided with this kit warns the user, "do not alter any kit/set component during insertions, use or removal (except as instructed).Examine catheter and extension lines before and after each treatment for any signs of damage." the customer report of a catheter leak during use was confirmed by visual inspection of the customer supplied photo and video.The photo displayed backflow blood in the arterial line.The video revealed the arterial line had air bubbles traveling through non-arrow extension tubing that was connected to the arterial luer hub.Without the sample returned, full complaint verification testing could not be performed and the probable cause could not be determined.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• 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
• MDR Report Key: 16306186
• MDR Text Key: 308879675
• Report Number: 9680794-2023-00058
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K141051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: CS-15232-VFE
• Device Lot Number: 13F22B0678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED