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 01/12/2023

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 10 days after line inserted.The catheter was sucking air during dialysis and unable to run blood pump more than 150ml/min.There was no patient harm due to the machine safety mechanism, but the patient missed treatment for the day.The catheter was replaced and no further issue was noted.Patient was reported to be "unstable inpatient in the hospital".Additional information received 01feb2023 reports "the patient is doing fine now" and the missed treatment didn't have any extended stay in the hospital.

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided one photo and one video for analysis.The complaint of extension line leak during use was able to be confirmed by the photo/video.The photo revealed blood backflow in the arterial line and the video revealed air flowing through the catheter which is evidence of a leak within the extension line.However, a complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed with multiple findings.It was determined that the findings are not relevant to the reported complaint.The ifu provided with the kit informs the user, "repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure".Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer reports "the retrograde catheter has issue of sucking the air during dialysis".Catheter was found sucking air from the arterial lumen 10 days after line inserted.The catheter was sucking air during dialysis and unable to run blood pump more than 150ml/min.There was no patient harm due to the machine safety mechanism, but the patient missed treatment for the day.The catheter was replaced and no further issue was noted.Patient was reported to be "unstable inpatient in the hospital".Additional information received 01feb2023 reports "the patient is doing fine now" and the missed treatment didn't have any extended stay in the hospital.

Manufacturer Narrative

Qn# (b)(4).The customer provided one video and one photo for analysis.Visual analysis of both showed the hemodialysis catheter inside the patient.No obvious damage/leaking was observed.The customer returned one chronic hemodialysis catheter for evaluation.Signs of use were observed on the catheter body and inside the extension lines.It was observed that the catheter body was severed.The severed end was not returned for analysis.Initial visual inspection of the catheter did not reveal any obvious defects or anomalies.After performing functional testing (see below), the compression cap was removed.It was immediately noted that the green compression sleeve was not present, which is not the intended assembly for this device.The sample was tested per bs en iso 10555-1, section 4.7.1 (amrq-000075) which states, "there shall be no liquid leakage in the form of a falling drop of water at 300-320 kpa (43.5-46.4 psi) for 30 sec when tested per bs en iso-10555-1 annex c".Both extension lines were attached to the leak tester.The lines were pressurized to 300 kpa and held for 30 seconds.Leaking was observed at the connection between the compression cap and the catheter body.The compression cap was unthreaded from the connector assembly.After removal, it was immediately noted that the green compression sleeve was not present, which is not the intended assembly for this device.A device history record review was performed with multiple findings.It was determined that the findings were not relevant to the complaint event.The ifu provided with the kit informs the user, "the separate hub connection assembly is then fastened to the proximal end of the catheter using a compression sleeve and threaded compression cap".The ifu also states, "thread compression cap onto hub connection assembly firmly, but do not over tighten.There should be no threads visible on hub connection assembly".The ifu also states, "slide threaded compression cap and compression sleeve (pre-loaded on tunneler handle) onto catheter and beyond cut mark".The report of a leaking extension line was confirmed through complaint investigation.Visual and functional analysis confirmed a leak between the connector fitting and catheter body.Further analysis revealed that the green compression sleeve was not included on the catheter assembly, which is not the intended assembly for this device.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, intentional user error likely caused or contributed to this event as the customer did not assembly that catheter per the ifu.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer reports "the retrograde catheter has issue of sucking the air during dialysis".Catheter was found sucking air from the arterial lumen 10 days after line inserted.The catheter was sucking air during dialysis and unable to run blood pump more than 150ml/min.There was no patient harm due to the machine safety mechanism, but the patient missed treatment for the day.The catheter was replaced and no further issue was noted.Patient was reported to be "unstable inpatient in the hospital".Additional information received 01feb2023 reports "the patient is doing fine now" and the missed treatment didn't have any extended stay in the hospital.

• 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: 16305477
• MDR Text Key: 308936657
• Report Number: 9680794-2023-00061
• 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,Followup
• Report Date: 01/17/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 03/06/2023; 03/06/2023
• Supplement Dates FDA Received: 03/07/2023; 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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.; NOT REPORTED.