MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM; CATHETER HEMODIALYSIS NON IMPL

Model Number IPN030096

Device Problem Expulsion (2933)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as, "involving (b)(6)-year-old patient in treatment for cardiac decompensation associated with cardio-renal syndrome (context : degeneration of a tavi (transcatheter aortic valve implantation) inserted in 2015.A dialysis catheter was inserted in the left jugular on (b)(6) 2020 to perform continuous hemofiltration that started on (b)(6) 2020 at 1 p.M.On (b)(6) 2020, at 7:30 p.M., during the patient's lateralization for nursing care, the catheter suddenly removed from his left jugular venous.Some blood spilled on the staff, on the bed and on the patient.The juncture hub remained in place.There was a minimal blood loss at the point of the puncture.Loss of blood in the circuit hemofiltration was approximately 200 ml.No other catheter was inserted." the patient's condition is reported as fine.It was reported the infectious risk for medical staff after bleeding is over.

Manufacturer Narrative

Qn# (b)(4).The customer returned one 2-lumen catheter and a representative catheter for evaluation.The actual juncture hub clamp and clamp catheter were not returned for evaluation.Visual examination of the returned samples did not reveal any defects or anomalies.Visual examination of the actual juncture hub clamp and clamp catheter could not be performed as they were not returned for evaluation.The outer diameter of the returned catheter body measured to be 4.68 mm which is within specifications of 4.62-4.72 mm per product drawing.Dimensional examination of the actual clamp catheter could not be performed as it was not returned for evaluation.The outer diameter of the representative catheter body measured to be 4.66 mm which is within specifications of 4.62-4.72 mm per product drawing.The inner diameter of the representative clamp catheter measured to be 4.06 mm which is within specifications of 3.9-4.5 mm per product drawing.To functionally test the device, the representative catheter clamp was attached to the actual and representative catheter bodies.The catheter bodies were then tugged in both directions while the clamp was held stationary.The clamp did not shift position on the catheter bodies and the catheters were not able to migrate.Functional examination of the actual juncture hub clamp and clamp catheter could not be performed as they were not returned for evaluation.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit instructs the user, "secure catheter to patient.Use triangular juncture hub with integral rotating suture wings as primary suture site." the customer report of a catheter migration could not be confirmed by complaint investigation of the returned sample.The actual and representative samples passed all relevant visual, dimensional, and functional testing.A device history record review was performed with no relevant findings.The probable root cause could not be determined based on the sample received and without the actual clamp catheter and juncture hub clamp to evaluate.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The complaint is reported as: "involving 65-year-old patient in treatment for cardiac decompensation associated with cardio-renal syndrome (context : degeneration of a tavi (transcatheter aortic valve implantation) inserted in 2015.A dialysis catheter was inserted in the left jugular on (b)(6) to perform continuous hemofiltration that started on (b)(6) at 1 p.M.On (b)(6) at 7:30 p.M., during the patient's lateralization for nursing care, the catheter suddenly removed from his left jugular venous.Some blood spilled on the staff, on the bed and on the patient.The juncture hub remained in place.There was a minimal blood loss at the point of the puncture.Loss of blood in the circuit hemofiltration was approximately 200 ml.No other catheter was inserted." the patient's condition is reported as fine.It was reported the infectious risk for medical staff after bleeding is over.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM
• Type of Device: CATHETER HEMODIALYSIS NON IMPL
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10710710
• MDR Text Key: 212285944
• Report Number: 3006425876-2020-00892
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K991431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

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 Operator: Health Professional
• Device Model Number: IPN030096
• Device Catalogue Number: CS-15142-CF
• Device Lot Number: 71F20F1918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 11/16/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Patient Age: 65 YR