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

Model Number N/A

Device Problem Infusion or Flow Problem (2964)

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

Event Date 08/30/2022

Event Type  Injury  

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.Implanted date: requested, not provided.Explanted date: requested, not provided.Initial reporter health professional: unknown.Initial reporter occupation: senior territory manager.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Review of the manufacturing record and the shipping inspection record of the actual product confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report for the involved product code/lot number combination.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Event Description

The user facility reported that the oxygenator device involved had high rpm and low flow on centrifugal.There was decreased sv02 and decrease cerebral sats.First, user changed out centrifugal motor and there was no change.Then, the device was then switched out and the new oxygenator performed as expected.To be determined after waking and neuro check.No pre or post oxygen pressure was measured.The surgery was competed successfully.Additional information was received on 19 sep 2022: the event occurred during bypass.The malfunction did not cause or contribute to an injury or death.Blood loss was less than 100cc's.

Manufacturer Narrative

This report is being submitted as follow up no.1 to add additional information to section b5, provide the device return date in section d9, update section h3, and to provide the completed investigation results.The initial mdr was "inadvertently" submitted with the incorrect b4 date, 09/21/2022.Section b4 has been updated to reflect the correct date.The actual sample was returned for product evaluation.Visual inspection of the actual sample upon receipt did not find any anomaly such as a breakage that could lead to the flow rate failure.After rinsing and drying the actual sample, it was installed into a circuit consisting of tubes, and bovine blood (hct: 35%, temp.: 37°c) was circulated.It was confirmed that a maximum blood flow rate of 5 l/min could be obtained.After the investigation, the pressure drop when circulating at a flow rate of 5l/min was measured.It was confirmed to meet the factory's specifications and no obstruction was found.The amount of oxygen transfer and carbon dioxide gas removal of the actual sample were measured.It was confirmed to meet the control standard values in the factory's specifications.·[bovine blood conditions] hb: 12g/dl, temp.: 37°c., ph: 7.4, svo2: 65%, pvco2: 45mmhg.·[circulation conditions] blood flow rate: 5l/min and 3l/min, v/q:1, fio2: 100%.·[o2 transfer volume] @5l/min: 304ml/min., @3l/min: 203ml/min.·[co2 removal volume] @5l/min: 253ml/min., @3l/min: 174ml/min.Saline solution was flowed in the blood channel.No blood clot that led to the obstruction was formed.Based on the investigation result, no anomaly leading to the obstruction was found in the actual sample after rinsing, and no anomaly in the gas transfer performance was also found.As a cause of occurrence, it was inferred that blood-derived obstructing occurred for some reason, which caused a decrease in flow rate and svo2, or blood clots formed in the oxygenator, which hindered gas transfer.However, since there was no anomaly in the performance test of actual sample, it was not possible to clarify the cause of this complaint from the investigation result.The instructions for use (ifu: (capiox fx15) has the following warnings regarding blood clot formation: · "do not reduce heparin during circulation.Otherwise, blood clotting might occur.(warnings)".· "adequate heparinization of the blood is required to prevent it from clotting in the system.(warnings)".

Event Description

Additional information was received on 5 oct 2022: the event that occurred was typical of a high-pressure excursion event or hpe.The event occurs as a result of platelet formation on the oxygenator bundle; however, the reason for this event is not scientifically understood.

• 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 15474740
• MDR Text Key: 300566063
• Report Number: 9681834-2022-00191
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701206
• UDI-Public: 04987350701206
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1CX*FX15W
• Device Lot Number: 220208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2022
• 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