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

Catalog Number CX*FX25RW

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - no patient involved.Age & date of birth - no patient involved.Sex - no patient involved.Weight - no patient involved.Ethnicity - no patient involved.Race - no patient involved.Implanted date: no patient involved.Explanted date: no patient involved.The 510k - k130520.A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed no findings.Visual inspection upon receipt found that the sterile pack had been already opened with some breaks on the pack.Visual inspection of the outer box and the cushion materials found that they had been deformed on several locations.It cannot be determined when they had been deformed.Magnifying inspection of the breaks found that the breaks had been generated in the outward direction from the inside of the pack.To identify the location of the breaks, the actual sample was repacked in the manner same as that of the factory-retained unopened sample.The breaks were found to be located at the support arm's position.The thickness of the sterile pack was confirmed to be equivalent to that of the factory-retained sterile pack sample.Visual inspection of the support arm corresponding to the location of the breaks on the sterile pack did not find any anomaly, such as burrs on the surface, which could be a trigger of the generation of the breaks on the sterile pack.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation result it is likely the actual sample was subjected to unknown excessive force, due to which the support arm had excessively close contact with the sterile pack and damage the pack.It is likely that the actual sample was exposed to the excessive force during transportation or storage at the involved facility.The exact cause of the reported event cannot be definitively determined based on the available information.The ifu states: inspect the device and package carefully.Do not use if the package and/or device is damaged.(b)(4).

Event Description

The user facility reported while the staff was preparing stocks and was removing the oxygenator from the outer box they noticed the plastic packaging had a hole.The hole compromised the sterility of the oxygenator.Upon thorough inspection, the outer box was not compromised and there was no damage or puncture.The event occurred pre-treatment, therefore, no patient was involved.

• Brand Name: CAPIOX FX 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; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 7444015
• MDR Text Key: 106619947
• Report Number: 9681834-2018-00049
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K071494
• 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: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 171013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2017
• 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