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

Catalog Number CX*RX15RW30

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was returned for evaluation.Visual inspection upon receipt found that the cap had been removed from the blood outlet port and the blood outlet port had been crushed inward from the outside.The cap was not retuned.Reproductive testing was performed.The blood outlet port on an oxygenator sample, with the cap attached to it, was hit on a hard object.As the result, the cap and the blood outlet port got deformed.The configuration of deformation on the blood outlet port was confirmed to be similar to that observed on the actual sample.A review of the device history record and the product release decision control sheet of the reported product code/lot number combination was conducted with no findings.Ifu reference: inspect the device and package carefully.Do not use if the package and/or device is damaged.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation result, it is likely that the actual sample was exposed to some hitting force on the blood outlet port on the oxygenator module, resulting in the reported damage.(b)(4).

Event Description

The user facility reported when the perfusionist was opening the immediate capiox device box for surgery, they saw a squeezed area in the blood outlet area of the oxygenator.The event occurred pre-treatment and the patient was not harmed.

• Brand Name: CAPIOX RX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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: terry callahan ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921
• MDR Report Key: 7666176
• MDR Text Key: 113312316
• Report Number: 9681834-2018-00124
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350771056
• UDI-Public: 04987350771056
• Combination Product (y/n): N
• Reporter Country Code: CE
• PMA/PMN Number: K051997
• 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: 07/06/2018

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 Expiration Date: 04/30/2020
• Device Catalogue Number: CX*RX15RW30
• Device Lot Number: 170519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• 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