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

Catalog Number CX-CRZ04401A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombocytopenia (4431)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130520.The actual sample was received for evaluation.Visual inspection revealed no break or no other obvious anomaly that could have contributed to the decrease in platelet.The actual sample, after rinsed with normal saline poured by gravity drop, was subjected to visual inspection.As a result, blood clots were found to have been formed in the bottom side; however, it was not determined whether they were formed during the use or the return shipment to the factory.A review of the device history record and the product-release judgement record of the involved product code/lot# combination was conducted with no findings.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of normal product.The exact cause of the reported event cannot be definitively determined based on the available information.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 involved capiox custom pack was used during the procedure.Platelet count decreased markedly after pump started.Patient: bsa 0.2.Asd creation surgery.Act 480 sec.Pump time: 25 minutes.Platelet count: 135000/ microliter (pre-pump), 31000/ microliter (in 10 minutes), 23000/ microliter (off-pump).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 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: theresa mussaw ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 11054525
• MDR Text Key: 238676397
• Report Number: 9681834-2020-00254
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: CX-CRZ04401A
• Device Lot Number: 200911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2020
• 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: 4 DA
• Patient Weight: 3