MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX ARTERIAL FILTER; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Catalog Number CX-XR367M01

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for this product code.Implanted date: device was not implanted.Explanted date: device was not explanted.The 510k - k943917.The actual device was received for evaluation.Visual inspection revealed a crack had been generated on the blood inlet port.Saline solution was let to flow through the actual device.The saline solution leaked at the crack.The outside and inside diameters of the blood inlet port were measured at a point adjacent to the crack.They were confirmed to be comparable to those of the current product sample.A factory-retained sample of the involved product code was hit on the blood inlet port with a hammer.The blood inlet port was exposed to intensive shock force, resulting in the generation of a crack which was similar to that observed on the actual sample.A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed no findings.Ifu states: do not add excessive shock to the filter, such as tapping with forceps, during priming or bypass, as this could damage the product.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation, it is likely that the actual device was subjected to shock force on the blood inlet port and got cracked, resulting in the reported leak of the priming solution.(b)(4).

Event Description

The user facility reported that pre-treatment after the capiox custom pack circuit was set on the hlm; during priming, when the customer hit the actual sample with a hammer, the prime started to leak.It was found that the actual sample found a crack on the blood inlet port.

• Brand Name: CAPIOX ARTERIAL FILTER
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: mark vornheder ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7952572
• MDR Text Key: 123275218
• Report Number: 9681834-2018-00180
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052205
• 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: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: CX-XR367M01
• Device Lot Number: 180720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2018
• 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