MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Model Number IPN030157

Device Problem Air/Gas in Device (4062)

Patient Problem Air Embolism (1697)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint is reported as: "a couple of weeks ago, we had a patient suffer an air embolism just after standing up with a renal replacement circuit connected to a 20cm arrowgard line.Air was seen to be being dragged from the patient round the circuit.The line was positioned very close to a vygon central line.The insertion site was neck.Both were removed & examined.There was no evidence of air leak when they were injected with air after being submersed in water and no evidence of a leak when flushed with saline.The easiest explanation is perhaps that the line was moved during mobilisation but the people who were there say that this didn't happen.The patient did have a brief period of deterioration but recovered quite quickly with no ill effects and has been discharged from icu.".

Event Description

Customer complaint is reported as: "a couple of weeks ago, we had a patient suffer an air embolism just after standing up with a renal replacement circuit connected to a 20cm arrowgard line.Air was seen to be being dragged from the patient round the circuit.The line was positioned very close to a vygon central line.The insertion site was neck.Both were removed & examined.There was no evidence of air leak when they were injected with air after being submersed in water and no evidence of a leak when flushed with saline.The easiest explanation is perhaps that the line was moved during mobilisation but the people who were there say that this didn't happen.The patient did have a brief period of deterioration but recovered quite quickly with no ill effects and has been discharged from icu".

Manufacturer Narrative

(b)(4), the customer returned one, 2-lumen hemodialysis catheter.Signs of use in the form of biological material were observed.Visual analysis did not reveal any defects or anomalies.The catheter length from the juncture hub to the distal tip measured 217mm, which is within the specification limits of 207mm-227mm per the catheter product drawing.The catheter body outer diameter measured 4.69mm, which is within the specification limits of 4.62mm-4.72mm per the catheter extrusion product drawing.The catheter was assembled and functionally tested per the instructions for use (ifu).The ifu provided with this kit states , "prepare catheter for insertion by flushing each lumen and clamping or attaching injection caps to appropriate extension lines".The catheter was flushed with a lab inventory syringe filled with water; no leaks or blockages were detected.Amrq-000162 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 luer hubs of the catheter were connected to the leak tester.With the distal end occluded, the catheter was pressurized to 300kpa for 30 seconds.No leaks detected.A manual tug test confirmed both the arterial and venous luer hubs were securely attached to their extension lines.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with the kit informs the user, "practitioners must be aware of complications associated with central vein catheters including cardiac tamponade secondary to vessel wall, atrial or ventricular perforation, pleural and mediastinal injuries, air embolism, catheter embolism, thoracic duct laceration, bacteremia, septicemia , thrombosis, inadvertent arterial puncture, nerve damage, hematoma, hemorrhage, dysrhythmias, brachial plexus injury, cardiac arrhythmia, exsanguination, hemothorax, luminal thrombosis, pneumothorax , subcutaneous hematoma, and retroperitoneal bleed".The report of an air embolism could not be confirmed as part of this complaint investigation.The returned catheter met all relevant visual, dimensional, and functional requirements including leak testing performed per bs en iso-10555-1.A device history record review was performed based on a potential lot identified from a sales history review.No relevant findings were identified to suggest a manufacturing related issue.Based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM
• Type of Device: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• 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
• MDR Report Key: 16452398
• MDR Text Key: 310339040
• Report Number: 3006425876-2023-00195
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10801902009217
• UDI-Public: 10801902009217
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K993933
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN030157
• Device Catalogue Number: CS-25142-F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: VYGON CENTRAL LINE; VYGON CENTRAL LINE
• Patient Outcome(s): Other