MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 15 FR X 31 CM; CATHETER,HEMODIALYSIS, IMPLANTED

Catalog Number CS-15362-VSP

Device Problems Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It is reported after 2-3 weeks of usage it was noted that the dialysis was not effective.The doctor suspected re-circulation.

Manufacturer Narrative

(b)(4).The customer returned one hemodialysis catheter for evaluation.The catheter was separated into two parts and displayed signs of use.Visual examination of the catheter did not reveal any defects or anomalies.The returned catheter was tested by clamping the catheter body just below the juncture hub and pressurizing each of the extension lines with water using a lab inventory 10ml syringe.As each extension line was pressurized, the remaining extension line was observed for any water backflow.When the venous extension line was pressurized, backflow was observed from the arterial extension line.Therefore, the catheter did contain inter lumen crossover.A device history record review was performed and no relevant findings were identified.The reported complaint for a catheter inter lumen crossover was confirmed through functional testing of the returned complaint sample.When each extension line was pressurized with water, crossover was observed in the opposite extension line.Based on the testing performed, the probable cause is manufacturing related.A nonconformance request was initiated to further investigate this complaint issue.

Event Description

It is reported after 2-3 weeks of usage it was noted that the dialysis was not effective.The doctor suspected re-circulation.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 31 CM
• Type of Device: CATHETER,HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7517880
• MDR Text Key: 108373591
• Report Number: 1036844-2018-00145
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: CS-15362-VSP
• Device Lot Number: 23F17G0644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2017
• 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