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

Model Number	CX*FX15RW40
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the aseptic plastic bag swelled, and gas entered.The procedure outcome was not reported.The event occurred pre-treatment.There was no patient involved or harmed.
Additional Manufacturer Narrative
A1: patient information: (b)(6).D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: initial reporter name: unknown.E1: establishment name: (b)(6) university.E1: phone number: unknown.E3: occupation: others.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Manufacturing record and the shipping inspection record of the actual sample found no anomaly.No other similar issue has been reported.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.Visual inspection of the actual sample: it was confirmed that the packaging bag swelled.The packaging bag was unopened and showed no signs of tears or damage.Upon checking the product inside the packaging bag, no damage or other anomalies were found.It was revealed that while a sample of the involved product code and lot number had the packaging label and reservoir label facing the same direction, the actual sample had them faced in opposite directions, with the product rotated 180 degrees within the packaging bag.Simulation test using the sample of the involved product code and lot number: it was observed during the simulation test that the packaging bag became swollen when it was handled in a specific manner, where the edge of the bag was held causing the bag to spread.In addition, the product turned within the swelled packaging bag.The investigation results indicated that the actual sample had been rotated within the packaging bag.The simulation test result suggested the possibility that the packaging bag swelled when it was handled in the specific manner; however, the exact timing when this phenomenon occurred could not be clarified.Relevant instructions for use (ifu) reference: "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.".

• Brand Name: CAPIOX FX OXYGENATOR
• Common Device Name: 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: stephanie handy ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 9499890491
• MDR Report Key: 20662058
• Report Number: 9681834-2024-00199
• Device Sequence Number: 7285469
• Product Code: DTZ
• UDI-Device Identifier: 04987350701121
• UDI-Public: (01)04987350701121(17)270131(10)240214
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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 Model Number: CX*FX15RW40
• Device Catalogue Number: CX*FX15RW40
• Device Lot Number: 240214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 11/24/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male