MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 1ZZ*FX05REA

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Lot numbers: 190705, 190729, or 191023.Expiration date - lot.:190705 june 30, 2022; lot.:190729 june 30, 2022; lot.:191023; september 30, 2022.Udi: not required for product code.Implanted date: device was not implanted; explanted date: device was not explanted; occupation-ccp.Device manufacturer date - lot.: 190705 july 5, 2019; lot.:190729 july 29, 2019; lot.:191023 october 23, 2019.The actual device was not returned, therefore, an evaluation of the actual device was unable to be conducted.A picture was provided by the user facility, and revealed a formation of substance that seemed to be white clots on the oxygenator filter surface.The result of the performance test (the pressure drop measured during the circulation of bovine blood at hct 35% and temp.37° c) conducted before the shipment from the factory for the same fiber lot product as the actual product was reviewed, and it was confirmed that the performance value was confirmed to be within the control criteria.A review of the device history record and product-release judgement record of the involved product code/lot# 190705 or 190729 or 191023 combinations was conducted with no findings.Ifu states: do not reduce heparin during circulation.Otherwise, blood clotting might occur.Adequate heparinization of the blood is required to prevent it from clotting in the system.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the involved capiox device was used during cardiopulmonary bypass.Fibrin was pulsating on the fiber bundle.During cpb, ccp noticed what looked like to be fibrin pulsating on the fiber bundle.The device was not changed out, the surgery was completed successfully.There was no patient injury, and there was no blood loss.The approximate time of occurrence was 9:01am.The event did not delay the procedure.

Event Description

Additional information was received 06oct2020.The patient had no prior interventions.8:56 pre-cpb act = 431.On cpb: 9:01.9:14 act = 581.9:43 act = 999 (this is an unmeasurable value so the value could have been mid 400 or lower).9:58 act = 424.Off cpb at 10:07.About 45 minutes into case noticed clot.Cooled to 28 degrees.Hematologic workups are not done routinely on their patients.There were no unusual pre-op meds given to the patient.The patient was not on pre-op anticoagulants.They do not rap.They often see act values of 999 on numerous cases and they think this is an acceptable value.Their protocol for a target act values is 400 seconds.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide a correction.Additional information was inadvertently not provided in the initial report.Therefore, section b5 has been updated to provide the additional information received.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10704529
• MDR Text Key: 214617064
• Report Number: 9681834-2020-00215
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1ZZ*FX05REA
• Device Catalogue Number: ZZ*FX05REA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1