MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX SX10 OXYGENATOR/RESERVOIR; OXYGENTOR

Catalog Number CX*SX10R

Device Problem Dent in Material (2526)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2015

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned to the manufacturing facility for evaluation.Visual inspection of the actual sample confirmed the customer's observation.A crush was noted on the blood inlet port as well as on the gas outlet port.No other anomalies were noted on the rest of the device.The packing configuration of this product was checked on the factory reserve sample.It was found that the blood inlet port and the gas outlet port does not come into contact with any cushion materials in the box.Simulation testing was conducted.The capped blood inlet port and the gas outlet port of a current product sample were subjected to a pushing force respectively by being pushed against a flat plate, such as a desk.Crushes similar to those on the actual sample were duplicated on the ports.A review of the device history record and the product release decision control sheet of the involved product/lot # combination was conducted with no relevant findings.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be determined, based on the available information it is likely that the actual sample was exposed to some pushing forces from different directions on the blood inlet port and on the gas outlet port after having been taken out of the unit-box, resulting in the reported deformation on the ports.From the available information it cannot be determined definitely, when and how the actual sample was subjected to those pushing forces.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off." (b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4).

Event Description

The user facility reported breakage in the capiox sx10 device.Follow up communication with the user facility confirmed the following information: during the assembling of the device it was noted a squeezed area in the blood inlet of the oxygenator; the oxygenator was replaced; the procedure was completed successfully; and there was no harm to the patient.

• Brand Name: CAPIOX SX10 OXYGENATOR/RESERVOIR
• Type of Device: OXYGENTOR
• 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: 5313210
• MDR Text Key: 33936678
• Report Number: 9681834-2015-00259
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CE
• PMA/PMN Number: K960074
• 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: 12/02/2015,12/21/2015

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: 01/31/2017
• Device Catalogue Number: CX*SX10R
• Device Lot Number: 140228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/26/2015
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2015
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2014
• 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