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 Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.510(k)- k130520.The actual device was returned for evaluation.Visual inspection upon receipt of the actual sample, before taking it out of the unit box, found the individual tyvek pack had some scuffs on its surface.The actual sample was taken out of the unit box for further inspection.It was found that the tyvek magnifying inspection of the scuffs found that they had not been developed into the holes reported by the customer.The thickness of the tyvek pack was measured and confirmed to be equivalent to that of the factory-retained sample.Visual inspection of the original unit-box and cushion material found that they had been deformed.It is unknown when and how they got the damage.A review of the manufacturing record and shipping inspection record of the involved product/lot# combination was conducted with no relevant 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.It is likely that the actual sample came into excessive contact with the product packed in it and the cushion material due to intensive shock force the actual sample was exposed to during transportation or during being handled by the customer, resulting in the generation of the scuff on the tyvek pack.(b)(4).

Event Description

The user facility reported when the perfusionist was preparing stocks the capiox oxygenator plastic packaging got holes.The holes compromised the sterility of the oxygenator.The event occurred pre-treatment and the patient was not harmed.The procedure outcome was unknown.

• 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: 7645810
• MDR Text Key: 112872186
• Report Number: 9681834-2018-00113
• 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: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 171110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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