MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: requested, not provided.Age & date of birth: requested, not provided.Patient sex: requested, not provided.Weight: requested, not provided.Ethnicity: requested, not provided.Race: requested, not provided.Date of event: requested, not provided.Lot number: requested, not provided.Expiration date: unknown due to unknown lot number.Udi: n/a as this product is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: clinical engineer.Pma/510(k): k130280.Device manufacture date: unknown due to unknown lot number.The actual sample was not returned to ashitaka factory for evaluation.The provided photo was confirmed.It was found that the lock adapter was disconnected from the male connector of sampling system.Since the lot number was unknown, the manufacturing record and the shipping inspection record could not be reviewed.As a possible cause of this complaint, from our past experiences, it was inferred that since some kind of lubricant was adhered to the male connector, the lock adapter was disconnected when it was tightened.However, since the actual sample was not returned, it was not possible to confirm whether there was any adhering substance, and the cause of occurrence could not be clarified.Relevant ifu reference: " do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.(a.Set-up, caution)" 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 Description

The user facility reported that during priming, it was found that the lock adapter of sampling system was disconnected.The lock adapter was just pushed in and was used.The procedure outcome was not reported and the paitent was not harmed.There were no other devices or equipment used with the reported product.

• Brand Name: CAPIOX FX25 OXYGENATOR
• Type of Device: 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: gina digioia ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15329230
• MDR Text Key: 305512438
• Report Number: 9681834-2022-00168
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CX-FX25REV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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