MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-FX25RWV

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Information (3190)

Event Date 06/03/2019

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130520 the actual device was received for evaluation.Visual inspection revealed no obvious anomaly, including a break.The line to be subjected to a negative pressure was checked for any loosen caps and defective joints of the tube on the sampling line.No anomaly was confirmed.The actual sample was built into a circuit with tubes.Saline solution was filled in it from the quick prime port and circulated at the flow rate of 0.5l/min.And at 5.0ml.Min.Respectively.At either of the flow rates no air was pulled into the circuit.During the priming, the venous blood inlet port was exposed to some load.No air was pulled into the circuit.Subsequently, the venous blood inlet port was rotated.No air was pulled into the circuit.The lid of the reservoir was separated from the hard-shell body for further inspection of the state of the tubes housed.Both tubes were confirmed to have no break or no dislodgement.The tube connected to the venous blood inlet port was inspected more closely for the state of its joint to the venous blood inlet port.Any anomaly, including a break or misalignment at the joint, was not revealed with the o-ring gasket packing applied to the joint in the normal manner.Easy coming off the tube from the quick prime port: the tube connected to the quick prime port during the actual use was not returned for evaluation.Dimensional inspection of the quick prime port confirmed it was equivalent to that of the current product sample.A review of the manufacturing records found there has been no dimensional change on the molding die for this component.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.Ifu states: for air entrainment: make sure the caps of unused luer ports are tightened firmly to prevent the leakage.For easy coming off the tube from the quick prime port: band all connections in the circuit.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of the normal product.It is likely that air entrainment was due to: in the priming procedure, during priming by gravity, air remaining in the circuit was gathered inside the venous blood inlet port and, due to its buoyancy, tried to remain at the highest location inside the venous blood inlet port.Subsequently, after the initiation of the circulation, when the pressure of inflow exceeded the buoyancy of air bubbles, air bubbles started to be pushed into the tube and came out of the tube into the venous filter, resulting in the customer's observation of the presence of air bubbles around the bottom area of the reservoir.The venous blood line had a leak channel, e.G.A loosen joint of the tube or a loosen cap, and air was pulled into the reservoir through it.Easy coming off the tube from the quick prime port: the length of the portion of the tube inserted over the port was not sufficient.The inside diameter of the tube used in this procedure differed from that of the tubes which had been used previously.The tube used in this procedure had been inserted over a cap, by which the inner diameter had become larger than normal.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).Exemption number e2015022.

Event Description

The user facility reported air entrainment with the involved capiox fx25 device.During priming of the recirculation line only with no link to the operative circuit, the customer noted air bubbles around the bottom area in the reservoir, which seemed to be coming out around the bottom of the venous filter intermittently.He connected the line to the operative circuit and primed the whole circuit, then air bubbles disappeared.Easy coming off the tube from the quick prime port: the customer felt the tube connected to the quick prime port was prone to come off more easily than usual.The actual sample was used without change-out.The procedure outcome and patient impact was unknown.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 8743525
• MDR Text Key: 202218924
• Report Number: 9681834-2019-00107
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: CX-FX25RWV
• Device Lot Number: 190206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2019
• 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