MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CU-25122-F
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "a patient connected to a functional 5008 machine is received, who finishes his treatment after 5 minutes, causing alert in the equipment, the lines are reviewed and it is identified that they were inverted by dysfunction of the mahurkar catheter, which caused confusion when connecting the line in the equipment, therefore the machine is alarmed, the revision is carried out using the tweezers, accommodation of the lines and patency of the catheter, with no results.The patient presented irritability followed by tonic-clonic convulsion lasting 40 seconds, causing coagulation of the circuit and dialyzer.Venous return is performed with physiological solution that is connected to the alternate inlet of the venous line, which does not allow manual return.Direct maneuvers are performed with a syringe and resistance of the lines is perceived and it is verified that they are coagulated, so only the catheter is permeabilized and heparinized.Help is requested, a blood biometry sample is taken, levetiracetam 230mg is administered in travenously and the patient is left under observation for 30 minutes and is discharged home." the physician does not attribute the patient's tonic clonic seizures to the device.Additional information received reports "the patient has a history of seizures.She presented with an epileptic seizure lasting 30 seconds, nasal prongs were placed at 3l/ min and seizure subsided without administration of medication, without loss of consciousness; however, a dose of levetiracetam was administered." the patient's current condition is reported as "stable".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer report indicates that the customer reversed the lines during use and did not notice until the end of the procedure.Clinical and medical affairs were contacted and indicated that if the patient was discharged with the catheter still inserted, then it would be a chronic, long-term hemodialysis catheter and not an acute hemodialysis catheter.The ifu provided with the kit informs the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture".The ifu also states, "flush lumen(s) to completely clear blood from catheter".Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The customer report indicates that the customer reversed the lines during use and did no notice until the end of the procedure.Clinical and medical affairs also indicated that if the patient was discharged with the catheter still inserted, then it would be a chronic, long-term hemodialysis catheter and not an acute hemodialysis catheter.Based on these circumstances and without the sample returned, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "a patient connected to a functional 5008 machine is received, who finishes his treatment after 5 minutes, causing alert in the equipment, the lines are reviewed and it is identified that they were inverted by dysfunction of the mahurkar catheter, which caused confusion when connecting the line in the equipment, therefore the machine is alarmed, the revision is carried out using the tweezers, accommodation of the lines and patency of the catheter, with no results.The patient presented irritability followed by tonic-clonic convulsion lasting 40 seconds, causing coagulation of the circuit and dialyzer.Venous return is performed with physiological solution that is connected to the alternate inlet of the venous line, which does not allow manual return.Direct maneuvers are performed with a syringe and resistance of the lines is perceived and it is verified that they are coagulated, so only the catheter is permeabilized and heparinized.Help is requested, a blood biometry sample is taken, levetiracetam 230mg is administered in travenously and the patient is left under observation for 30 minutes and is discharged home." the physician does not attribute the patient's tonic clonic seizures to the device.Additional information received reports "the patient has a history of seizures.She presented with an epileptic seizure lasting 30 seconds, nasal prongs were placed at 3l/ min and seizure subsided without administration of medication, without loss of consciousness; however, a dose of levetiracetam was administered." the patient's current condition is reported as "stable".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 20831766
• Report Number: 3006425876-2024-01186
• Device Sequence Number: 4069978
• Product Code: DQY
• UDI-Device Identifier: 00801902100276
• UDI-Public: (01)00801902100276(11)230412(17)250130(10)71F23D0185(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2025
• Device Catalogue Number: CU-25122-F
• Device Lot Number: 71F23D0185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown