MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX CARDIOPLEGIA; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: no patient involvement.Age & date of birth: no patient involvement.Patient sex: no patient involvement.Weight: no patient involvement.Ethnicity: no patient involvement.Race: no patient involvement.Implanted date: no patient involvement.Explanted date: no patient involvement.Udi: n/a as this product code is not exported to the us market.Initial reporter occupation: occupation: clinical engineer.The actual device has been returned for evaluation.Visual inspection of the actual sample found no anomaly such as a breakage.Magnifying inspection of the actual sample found that; there were no abnormality such as deformation or a breakage on the lure port at the cardioplegia side; there were no abnormality such as deformation or a breakage at the connection of the luer thermistor.The tapered part of the lure port was confirmed to be normal.Leak test of the actual sample by a circulation of normal saline at 0.5l/min showed no dislodgement of connection that could lead 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 regarding the involved product code/lot found no other similar indications.During the investigation, no abnormalities such as deformation were found in the actual lure port and luer thermistor.In the manufacturing process of cardioplegia, to prevent cracks in the port due to excessive tightening of the luer thermistor, a special jig is used to control that the part is tightened consistently with a certain torque.Therefore, it was possible that the connection of the luer thermistor has become loose due to some factors before use, but it was not possible to clarify the timing of the loosening of the luer thermistor.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 during priming of the involved capiox custom pack, the luer thermistor came off the cardioplegia and became filthy, therefore the use was discontinued.The product was exchanged with a new circuit.The event occurred pre-treatment.There was no patient involvement and no patient harmed.

• Brand Name: CAPIOX CARDIOPLEGIA
• Type of Device: HEAT-EXCHANGER, 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 ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16465136
• MDR Text Key: 310532995
• Report Number: 9681834-2023-00030
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K982467
• 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: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: CX-BPD63701
• Device Lot Number: 220628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2022
• 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: PHYSIOLOGICAL SALINE SOLUTION AND POTASSIUM