MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX CUSTOM PACK; TUBING PACK

Catalog Number CX-XR270L04

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

Udi no.Not required for this product code.The actual device has been received by the manufacturing facility for evaluation.Visual inspection of the actual device did not reveal any obvious anomalies in its appearance.The investigation is currently ongoing.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.A review of the device history record and the product release decision control sheet of the involved product code/lot# combination was conducted with no relevant findings.A search of the complaint file did not find any other report with the involved product code/lot# combination.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported clogging in the capiox device during a procedure.Follow up communication with the user facility confirmed the following information: about twenty minutes after initiation of circulation, it was noticed that the actual device was not ultrafiltrating with the full flow rate; and the patient was not harmed.

Manufacturer Narrative

The actual device was returned to the manufacturing facility for evaluation.Visual inspection found no obvious anomalies.There was no clot formation inside the device.Saline solution flowed through the actual sample was noted to come out of the blood outlet side.The actual sample, after having been rinsed and dried, was circulated with bovine blood, while ultrafiltrating performance and the pressure drops were determined and confirmed to meet manufacturing specifications.A search of the complaint file found another previous report of this nature with the hemoconcentrator from the involved product/lot# combination, refer to mdr# 9681834-2016-00186.There is no evidence that this event was related to a device defect or malfunction.The investigation results verified that the actual sample was normal product.Although the exact cause of the reported event cannot be definitively determined based on the available information, it is likely that concentrated blood may have flowed into the actual device and occluded the fibers.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "the capiox hemoconcentrator is designed to operate at flow rates within the range of 100 to 500 ml/min during ultrafiltration.Do not use blood flow rates outside this range.Less than 100 ml/min blood flow may cause blood coagulation in the device." "do not exceed 50% hematocrit at the blood outlet during ultrafiltration." and "do not stop blood flow during extracorporeal circulation as it may cause clotting in the system.A blood flow at least 50 l/min is recommended even if ultrafiltration is stopped by clamping the filtrate line." all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The initial mdr stated that the user facility reported clogging during the use of a capiox device.We would like to update this by stating the following, the user facility reported clogging in the capiox hemoconcentrator (cx-hc11s, lot# 160316) built in the capiox custom pack (cx-xr270l04, lot# 160526) during a procedure.

• Brand Name: CAPIOX CUSTOM PACK
• Type of Device: TUBING PACK
• 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: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6075301
• MDR Text Key: 59046801
• Report Number: 9681834-2016-00247
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Type of Report: Initial,Followup
• Report Date: 11/03/2016

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: 10/31/2017
• Device Catalogue Number: CX-XR270L04
• Device Lot Number: 160526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 11/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• 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: 70 YR
• Patient Weight: 60