MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA UNK CAPIOX; OXYGENATOR, CARDIOPULMONARY BYPASS

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

Expiration date - unknown due to unknown product code/ lot number.Udi - unknown due to unknown product code/ lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to unknown product code/ lot number.Health professional: unknown.Occupation: unknown.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The production product code/ lot number 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 clotting per cec in the cardiotomy reservoir of a cec circuit in a terumo brand set.The procedure outcome was reported to be unknown.There was no harm to the patient.

• Brand Name: UNK CAPIOX
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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; 950 elkton blvd; elkton, MD 21921
• MDR Report Key: 8654133
• MDR Text Key: 146507298
• Report Number: 9681834-2019-00087
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 05/30/2019
• 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