MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HEMOCONCENTRATOR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number CX*HC11L

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted. Explanted date: device was not explanted. The actual device has been returned for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings. This report is for the first device reported, for the second device reported that was used on the same patient see mdr 9681834-2019-00235. (b)(4).

Event Description

The user facility reported that the capiox hemconcentrator was stuck and there was no function during bypass after two hours. They changed out the device to a new one to allow the procedure to keep going until the end. The procedure outcome and patient impact was reported to be unknown.

• Brand Name: CAPIOX HEMOCONCENTRATOR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• 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: 9606473
• MDR Text Key: 202724936
• Report Number: 9681834-2019-00239
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K973516
• 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,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/20/2020
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2022
• Device Catalogue Number: CX*HC11L
• Device Lot Number: 190510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial