MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX15 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Date 02/13/2023

Event Type  malfunction  

Event Description

The user facility reported leakage from the adapter of reservoir during priming.The operator rechecked the connection and replaced the tubing connector; however, the leakage still occurred.The product was replaced and there was no more leakage.The procedure outcome was not reported.The final patient impact was not harmed.

Manufacturer Narrative

Patient identifier: requested, unknown.Date of birth: requested, unknown.Weight: requested, unknown.Ethnicity: requested, unknown.Race: requested, unknown.Pma/510(k) - k130520.The actual sample was returned to the ashitaka factory.Visual inspection of the actual sample upon receipt found no external anomalies such as breakage.Leak test of the actual sample was performed as follows.Colored physiological saline solution was poured by a head of fluid into the priming port of the reservoir of the actual sample (in the same condition when received by ashitaka.) the actual sample was built into a circuit with tubing and colored physiological saline solution was circulated at 4l/min with a roller pump.No leakage was observed.The adapter was removed from the actual sample and inspected with a magnifying glass.No abnormalities such as deformation of threads or breakage were observed in the 1/4 adapter.No cracks or the like that could lead to leakage were observed in the blood outlet port of the reservoir.It is known from our experience that leakage may occur when some kind of load is applied to the 1/4 adapter during routing of the tube connected to the 1/4 adapter.In an assumption that the tube was exposed to a tensile load when connected to the roller pump, the 1/4 adapter was attached to the actual sample, and then a tensile load was applied to the tube in the lateral direction.As a result, leakage was observed at the connection of the 1/4 adapter.In an assumption that a torque load was applied to the tube, the 1/4 adapter was attached to the actual sample and a torque load was applied to the tube.As a result, the connection of the 1/4 adapter became loose, leading to leakage.Review of the manufacturing record and shipping inspection record of the actual sample found no anomaly in them.A search of the past complaint file of the involved product code/lot found no other similar reports.The investigation result showed no anomaly that could lead to the leakage in the actual sample.As for the cause of this incident, it is possible that some kind of load was applied to the 1/4 adapter and a leakage path was created at the connection between the 1/4 adapter and the blood outlet port of the reservoir, which resulted in the leakage.However, no leakage was confirmed with the actual sample during the above leak test, the cause could not be clarified.Relevant instructions for use (ifu) reference: "ensure that all connected parts including the luer caps, the lock adapters and the port caps are securely affixed.Loose connections may cause contamination or a blood leak." 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 leakage from the adapter of reservoir during priming.The operator rechecked the connection and replaced the tubing connector; however, the leakage still occurred.The product was replaced and there was no more leakage.The procedure outcome was not reported.The final patient impact was not harmed.

Manufacturer Narrative

Patient identifier: requested, unknown.Date of birth: requested, unknown.Weight: requested, unknown.Ethnicity: requested, unknown.Race: requested, unknown.Pma/510(k) - k130520.The actual sample was returned to the ashitaka factory.Visual inspection of the actual sample upon receipt found no external anomalies such as breakage.Leak test of the actual sample was performed as follows.Colored physiological saline solution was poured by a head of fluid into the priming port of the reservoir of the actual sample (in the same condition when received by ashitaka.) the actual sample was built into a circuit with tubing and colored physiological saline solution was circulated at 4l/min with a roller pump.No leakage was observed.The adapter was removed from the actual sample and inspected with a magnifying glass.No abnormalities such as deformation of threads or breakage were observed in the 1/4 adapter.No cracks or the like that could lead to leakage were observed in the blood outlet port of the reservoir.It is known from our experience that leakage may occur when some kind of load is applied to the 1/4 adapter during routing of the tube connected to the 1/4 adapter.In an assumption that the tube was exposed to a tensile load when connected to the roller pump, the 1/4 adapter was attached to the actual sample, and then a tensile load was applied to the tube in the lateral direction.As a result, leakage was observed at the connection of the 1/4 adapter.In an assumption that a torque load was applied to the tube, the 1/4 adapter was attached to the actual sample and a torque load was applied to the tube.As a result, the connection of the 1/4 adapter became loose, leading to leakage.Review of the manufacturing record and shipping inspection record of the actual sample found no anomaly in them.A search of the past complaint file of the involved product code/lot found no other similar reports.The investigation result showed no anomaly that could lead to the leakage in the actual sample.As for the cause of this incident, it is possible that some kind of load was applied to the 1/4 adapter and a leakage path was created at the connection between the 1/4 adapter and the blood outlet port of the reservoir, which resulted in the leakage.However, no leakage was confirmed with the actual sample during the above leak test, the cause could not be clarified.Relevant instructions for use (ifu) reference: "ensure that all connected parts including the luer caps, the lock adapters and the port caps are securely affixed.Loose connections may cause contamination or a blood leak." 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).

• Brand Name: CAPIOX FX15 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: 16520635
• MDR Text Key: 311110603
• Report Number: 9681834-2023-00042
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701169
• UDI-Public: 04987350701169
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• 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*FX15RW30
• Device Lot Number: 220520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2022
• 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
• Patient Age: 5 YR
• Patient Sex: Male