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

Model Number N/A

Device Problem Decrease in Pressure (1490)

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

Event Date 07/06/2023

Event Type  malfunction  

Event Description

The user facility reported that it was an emergency case, mera oxygenator of mera l-circuit was used initially.As the oxygenation performance decreased, around 4:15, fx15 only from xry39001 circuit was used to perform ecc.Afterward, the performance of fx15 decreased also.After pumping, they proceeded to pcps, however, though the performance was improved somewhat when the patient was cooled, overall gas exchange performance was poor for both mera and fx15.It was an emergency case, the patient's tg was about 3700, and the blood inside the circuit seemed white possibly due to fat.The procedure outcome was not reported.The patient was not harmed.

Manufacturer Narrative

A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3: patient sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D4: udi: n/a as this product is not exported to the us market.D6a: implanted date: requested, not provided.D6b: explanted date: requested, not provided.E3: occupation: clinical engineer.G4: pma/510(k) - k130520.1.Inspection of the actual sample: 1.1.Visual inspection of the actual sample upon receipt found no anomaly such as a breakage.1.2.The actual sample was filled with glutaraldehyde-containing saline solution and fixed, the housing and filter were removed, and visual inspection of the gas transfer part was performed.No anomaly was found in the condition of fiber winding.White adherents were found on the removed filter.1.3.The fiber layer was removed gradually, and visual inspection of the gas transfer part was performed.No anomaly was found in the condition of fiber winding.1.4.The heat exchanger was removed from the outer cylinder and subjected to visual and magnifying inspection.White adherents were found.No deformation or other anomaly that could lead to an obstruction was found in the heat exchanger.2.Review of pump record: it was confirmed that extracorporeal circulation started at 23:44.An arrow was written in the pump record just after 4:14, in addition, from the information that the mera oxygenator was exchanged with fx15 at 4:15, it was thought that the exchange of oxygenator was done at this time.Po2 recorded at around 4:34, after exchanging mera with fx15, was 261mmhg.The circulation conditions at this time could not be read from the pump record.A second arrow was written around 5:09, and pcps was also written below it, so it was thought that pcps was introduced at this time.3.History investigation: 3.1.Review of the manufacturing record and the shipping inspection record of the actual sample found no anomaly.3.2.Review of the past complaint file found no other similar report on the involved product code/lot number.3.3.Manufacturing date: november 29, 2022.4.Cause of occurrence/conclusion: during the investigation, white adherents were found inside the actual sample.Though the white adherents were found, as for the cause of occurrence, the causal relation between the white adherents and the poor gas transfer performance was not clarified.In addition, it was not possible to clarify its properties from the results of the investigation.Relevant ifu reference: "measure blood gases and make necessary adjustments as follows.A.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.B.Control paco2 by changing the total gas flow.To decrease paco2, increase total gas flow.To increase paco2, decrease total gas flow." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• Brand Name: CAPIOX CUSTOM PACK
• 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: 17465651
• MDR Text Key: 321112585
• Report Number: 9681834-2023-00156
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• 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: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• 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-XRY39001
• Device Lot Number: 221129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2022
• 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
• Treatment: CDI; S5