MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA ARTERIAL FILTER; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Catalog Number ZZ*AF125XA

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 05/28/2019

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k943917.The actual device was not returned to the manufacturing facility for evaluation.However, images showing the actual sample were provided and reviewed.A leak was noted at the cock component of the three-way stopcock connected to the actual sample.A retention sample from the involved product code/lot# combination was evaluated.Visual inspection revealed no anomaly, such as a break, in the appearance.The female lure of the vent port to be connected to a three-way stopcock was dimensionally checked for its taper (angle and dimension) with the luer taper gauge which conforms to iso standard, it was confirmed to meet the manufacturer specifications.The retention sample was filled with saline solution.With the blood outlet port being clamped, the blood phase was pressurized with an air of 1.6kgf/cm2 sent into it from the blood inlet port.No leak was observed.Subsequently, a factory-retained three-way stopcock was connected to the female luer of the port and the same leak test was conducted.No leak occurred.The involved device was not returned for evaluation.Therefore, the investigation was based on user facility information, provided image, and evaluation of the retention sample.The investigation results verified the retention sample was of the normal product.However, with no return of the actual sample, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the event involving the capiox arterial filter occurred when perfusionists was conducing cpb, he noticed a blood leak from three-way stopcock located in arterial filter.In the middle of three-way stopcock there was blood leaking without any interference with good and normal perfusion procedure.However, it was the second time that something like that occurred.There was no blood loss during the procedure.There was no disposable replaced, and the perfusionists replaced only three-way stopcock with another one from an unknown company.The patient impact and procedure outcome was reported to be unknown.

• Brand Name: ARTERIAL FILTER
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 8743527
• MDR Text Key: 160053173
• Report Number: 9681834-2019-00112
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K052205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: ZZ*AF125XA
• Device Lot Number: 180320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2019
• 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