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

Model Number N/A

Device Problem Noise, Audible (3273)

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

Event Date 06/02/2022

Event Type  Injury  

Event Description

The user facility reported that during extracorporeal circulation, an abnormal noise (sound of drawing in air) was generated from the positive pressure relief valve on the caipox custom pack involved.It was inferred that the noise was caused by the ball in the positive pressure relief valve.When a cap was put on it, the noise stopped; when the cap was removed, it started to make noise again.Therefore, the problem was solved by vibrating the positive pressure relief valve with a finger to shift the position of ball.The event occurred intra-operative.There was no patient injury/medical or surgical intervention required.The patient was not harmed.

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.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation - clinical engineer.Pma/510(k) - k130520.Visual inspection of the actual sample did not find any anomaly such as a breakage that could lead to the drawing in air in the appearance of the positive pressure relief valve and other sections.Review of the manufacturing record and the shipping inspection record of the actual sample confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination.Looseness of the cap connected to each port on the top of actual reservoir was confirmed.No looseness was found.After rinsing the actual sample, in order to confirm the event described in the reported issue, the inside of the reservoir was sucked with a vacuum pump and a negative pressure (maximum -150mmhg) was gradually applied to check for abnormal noise and drawing in air.As a result, no abnormal noise and drawing in air was found, and the event described in the reported issue could not be simulated.After disassembling the positive pressure relief valve of actual sample, magnifying inspection was performed for the internal state.No anomaly such as catching of foreign substance or breakage was found.Magnifying inspection of the ball taken out from the positive pressure relief valve of actual sample did not find any anomaly such as a deformation.Then, the dimension of ball was measured and compared it with a factory-retained product.No difference was found.Based on the investigation result, no anomaly such as catching of foreign substance or breakage was found in the positive pressure relief valve of actual sample that could lead to the drawing in air.As a cause of abnormal noise, it was inferred that there was a gap in the adhered section of positive pressure relief valve for some reason.However, it was not possible to identify the cause of occurrence from the condition of actual sample.(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: stephanie handy ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 9499890491
• MDR Report Key: 14797571
• MDR Text Key: 294649445
• Report Number: 9681834-2022-00118
• 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: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CX-CRX07802A
• Device Lot Number: 220208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• 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