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

Catalog Number CX-BPU13501

Device Problem Complete Blockage (1094)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

Udi no.- not required for this product code.The actual device was not returned to the manufacturing facility for evaluation.Therefore, the investigation consisted of review of user facility information, manufacturer quality records, and evaluation of a retention sample from the reported product code/lot# combination.Visual inspection found no obvious anomalies.The retention sample was circulated with bovine blood, while ultrafiltrating performance and the pressure drop was determined.They were confirmed to meet manufacturing specification.The sample was rinsed and the housing components were removed for further inspection of the state of the fibers.Magnify inspection of the fibers revealed no anomalies or no occlusion in the fibers.A review of the device history record of the product code/lot# combination was conducted with no relevant findings.The same customer reported a similar event for another device with the same product code/lot# combination.See mdr 9681834-2016-00251 for details.There is no evidence that this event was related to a device defect or malfunction.The investigation results verified that the retention sample was the normal product.An exact cause of the reported event cannot be definitively determined.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.Actual device not available.

Event Description

The user facility reported clogging in the capiox hemoconcentrator (cx-hc11s, lot#151219) built in the capiox custom pack (cx-bpu13501, lot#160427) during a procedure.Follow up communication with the user facility confirmed the following information: the device became occluded several hours after initiation; act was controlled >500 sec.During the procedure; the actual sample was positioned beside the reservoir about 40 - 50cm above the floor; the actual device was changed out; blood loss was reported, a specific amount is unknown; and the patient was not harmed.

• 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: 6089852
• MDR Text Key: 59507803
• Report Number: 9681834-2016-00252
• 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
• Report Date: 11/09/2016

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: 09/30/2017
• Device Catalogue Number: CX-BPU13501
• Device Lot Number: 160427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2016
• 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