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

Model Number N/A

Device Problem Obstruction of Flow (2423)

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

Event Date 05/22/2023

Event Type  malfunction  

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 no: n/a as this product code is not exported to the us market.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: clinical engineer.G4: 510(k) no: k071494, k130520.Inspection of the actual sample: 1: the actual sample in the state as received was subjected to visual inspection, and no breakage was found in it.2: the reservoir of the actual sample was disassembled and subjected to visual inspection.There was no damage that could lead to decreasing venous blood flow rate in the venous inlet drop tube inside the defoamer of the venous filter.[?] there was no formation of blood clots that could lead to decreasing venous blood flow rate in the defoamer of the venous filter.Formation of blood clots was observed in the cr filter.3: the oxygenator was filled with glutaraldehyde-containing normal saline and fixed, then the oxygenation module was separated from the housing and filter and inspected visually.No anomaly was found in the condition of fiber winding.4: the oxygenation module was inspected visually while the fiber layer was removed gradually.[?] formation of blood clots was observed.No anomaly was found in the condition of fiber winding.5: the heat exchanger was removed from the outer cylinder and subjected to visual and magnifying inspections.No deformation that could lead to an obstruction was found in the heat exchanger.Record review: review of the manufacturing record and the shipping inspection record of the actual sample found no anomaly.Review of the past complaint file found no other similar report on the involved product code/lot#.Cause of occurrence/conclusion: according to the investigation results, the formation of blood clots was observed in the actual sample; however, no anomalies that could lead to decreasing venous blood flow rate, such as a breakage, was observed in the actual sample.Since no anomaly that could lead to the reported event was observed in the actual sample, the cause in this case could not be clarified.Relevent ifu reference: "do not reduce heparin during circulation.Otherwise, blood clotting might occur.Adequate heparinization of the blood is required to prevent it from clotting in the system." terumo medical products (tmp) (importer) registration no.(b)(6) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Event Description

The user facility reported that during cpb, while using oxygenator as usual, they felt that venous blood flow rate was low.While there were no changes in the pressure loss of the oxygenator and vavd pressure, there was a timing when the venous blood flow decreased, though the drop was less than 1l.It was not serious enough to replace the oxygenator, and they continued using it.The procedure was completed successfully.The patient was not harmed.

• Brand Name: CAPIOX CUSTOM PACK
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• 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: 17168147
• MDR Text Key: 318012621
• Report Number: 9681834-2023-00101
• 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: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CX-XRX55003
• Device Lot Number: 221222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/20/2023
• Date Device Manufactured: 12/22/2022
• 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