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

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k943917.Device manufacture date - unknown due to unknown lot number.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The production product code/lot number combination was not provided by the user facility, which prevented a meaningful review of the device history record.With no return of the actual device, 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 key of the tracks that comes with the capiox arterial filter presents leaks.The actual sample was changed out.There was no immediate patient impact.The procedure outcome and final patient impact was reported to be unknown.

• Brand Name: UNK CAPIOX ARTERIAL FILTER
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 8491341
• MDR Text Key: 141196839
• Report Number: 9681834-2019-00049
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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