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

Catalog Number CX-FX25RWV

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/30/2021

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- clinical engineer.Pma/510(k)- k130280.The actual lock adapter sample was only returned for evaluation.Visual inspection revealed no breakage or similar anomaly in the appearance.Magnifying inspection of the actual sample found no deformity or similar anomaly in the appearance.The inner diameter was measured.Compared to a current product sample, no difference was observed in the measured values.Reproductive testing was performed, and silicone was applied to a male connector of a factory-retained sampling system, a female connector was connected to it, and then a lock adapter was tightened up.As a result, the lock adapter came off.Ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.A review of the device history record and the product-release judgement record of the involved product code/lot# combination was conducted with no findings.It is likely that to be that some kind of lubricant was adhering to the male connector of the sampling line, and when the lock adapter was retightened, it may have get over the rib of the male connector and come off.However, with no return of the actual sampling line sample, 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 Description

The user facility reported that the capiox device was used pre-treatment.Dislodgement of lock adapter occurred during priming.The locking adapter on the arterial side of the sampling line came off even though no special force was applied.The procedure outcome was not reported.The patient was not harmed.

• 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 11884168
• MDR Text Key: 261948179
• Report Number: 9681834-2021-00088
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: CX-FX25RWV
• Device Lot Number: 201201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• 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