MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX15; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	CX*RX15RW30
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Phone number- requested, not provided.The actual sample has been received for evaluation.Visual inspection revealed that sterile bag was unopened, and a hole had been generated on the nonwoven fabric.The unit box with cushioning material that had contained the actual sample was visually inspected and found that it had been deformed in multiple points.It could not be clarified when the unit box was deformed.Magnifying inspection of the hole revealed that it had been made from the inside of the sterile bag.The thickness of the sterile bag material was measured and confirmed to be equivalent to that of a manufacturer retention sample.The sampling system contained in the sterile bag, on the top of reservoir was confirmed to have been located beneath the point on the nonwoven fabric where the hole was generated.Based on this, the sampling system was inspected visually and confirmed to have no burrs that could make a hole on the nonwoven fabric.A review of the device history record and the product release judgement record of the involved product code/lot number combination revealed no findings.Ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that since the unit box was deformed, it is likely that an excessive load was applied while the actual sample was in the unit box, causing a hole at the point where the reservoir was in contact with the sterile bag.It is likely to be due to handling during storage period why the actual sample was subjected to such an excessive load.However, the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported that the involved capiox device was used pre-treatment.After they opened the box, the perfusionist found aseptic package broken.The procedure outcome and patient outcome was not reported.

• Brand Name: CAPIOX RX15
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10372189
• Report Number: 9681834-2020-00153
• Device Sequence Number: 3446488
• Product Code: DTZ
• UDI-Device Identifier: 04987350771056
• UDI-Public: 04987350771056
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: CX*RX15RW30
• Device Lot Number: 191011C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 28