MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF; BLOOD GAS OXYGENATOR

Catalog Number CX*FX15RW40

Device Problems Air Leak (1008); Use of Device Problem (1670); Human Factors Issue (2948)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4) - patient experienced a stroke post surgery.The actual device has been received but the evaluation is not yet complete.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 device history record of the involved product/ lot number combination confirmed there were not any indications of production-related problems.A review of the shipping inspection record of the involved product code/lot number combination confirmed there was no discrepancy or non-confirming in the inspection/test result.There was no indication of anomaly in the air removing performance of the device.A review of the material incoming inspection record confirmed that there was no dimensional anomaly in the filter used for the actual sample.A search of the complaint file found no other report of this nature with the involved product code/lot number.As stated, there were two incidents from this facility for the same issue.Please refer to mdr no.9681834-2015-00184.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending and follow up.Actual device not returned.

Event Description

The user facility reported air bubbling in the capiox fx15 device during a procedure.Follow up communication with the user facility reported that there were two incidents related to patient stroke post surgery using the fx15 oxygenator device.

Manufacturer Narrative

This report is being submitted as follow-up #1 for mfg.Report #9681834-2015-00183 to provide the retention sample evaluation results as well as corrections to the initial report.(b)(4) patient experienced a stroke post-surgery.The actual device is not available for evaluation.Therefore, the investigation was limited to a review of the user facility information, quality records, and evaluation of a retention sample from the involved product/lot number.Visual inspection did not find any obvious anomalies in the appearance conditions.Magnifying inspection of the filter did not reveal any anomalies in the appearance.The sample was tested for the foreign substance eliminating performance in accordance with the factory's shipping test protocol and verified to be normal.The sample was tested for the de-bubbling performance in accordance with the factory's shipping test protocol and verified to be normal.A review of the device history record of the involved product/lot# combination confirmed there were no indications of production-related anomalies.A search of the complaint file did not find any other report with the involved product/lot# combination.There were two incidents from this facility for the same issue reported at the same time.Please refer to mdr no.9681834-2015-00184.The investigation result verified that the retention sample was the normal product.With the absence of the actual sample to be evaluated, neither the cause of this complaint nor the cause and-effect relationship between the device and the reported stroke post-surgery can be definitively determined.The device labeling does address the potential for such an event in the instruction for use (ifu) with statements such as the following: (1) when capiox fx15 oxygenator module is used separately from the hardshell reservoir, set the module so that the upper end of the fibers is lower than the blood level in the venous reservoir.This prevents gaseous emboli from entering the blood phase from the gas phase.(2) when using the centrifugal pump on the arterial line, clamp the arterial line distal to the oxygenator (the patient's side) before stopping the pump.Improper clamping may cause back-flow of blood or migration of gaseous emboli into the blood side.(3) minimum operating volume in r40 reservoir is 200 ml and 70 ml in r30 reservoir.Set appropriate blood storage level, relative to venous flow rate, to prevent gaseous emboli passing to patient.(4) use of a recirculation line is recommended in the arterial line after the fx oxygenator to facilitate gaseous emboli removal during priming and emergency situations.(5) use the safety devices, including the level sensor and the air detector, in order to control the volume of the blood in the reservoir and to detect gaseous emboli in the arterial lines.(6) do not obstruct gas outlet port.Avoid buildup of excess pressure in the gas phase to prevent gaseous emboli entering the blood phase.(7) pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase.(8) the gas flow rate should not exceed 15 l/min.Excessive gas flow rate will bring about pressure increase in the gas phase, allowing gaseous emboli to enter the blood phase.(9) during recirculation, do not use pulsatile flow and do not stop the blood pump suddenly as these actions may cause gaseous emboli to enter the blood phase from the gas phase due to inertia force.(10) to prevent gaseous emboli from entering the blood phase, make sure that the arterial pump flow rate always exceeds the flow rate of the cardioplegia line.The blood flow rate of the cardioplegia line should not exceed 1l /min.(11) returning the priming solution back to the cardiotomy filter when there is an insufficient level of solution contained within the reservoir may generate gaseous emboli.Maintain an adequate level of solution in the reservoir.(12) do not exceed a 15°c (27°f) temperature difference between blood and water in heat exchanger to prevent gas dissolved in blood from forming bubbles.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.(b)(4).

Event Description

This report is being submitted as follow-up #1 for mfg.Report #9681834-2015-00183 to provide the retention sample evaluation results as well as corrections to the initial report.It was reported in the initial report that the user facility reported bubbling in the capiox fx15 device.That is not the case, the devices is being reported due to it being used on a patient that experienced a stroke post-surgery.

• Brand Name: CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF
• Type of Device: BLOOD GAS OXYGENATOR
• 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: kathleen little ; reg. no. 2243441; 2101 cottontail ln.; summerset, NJ 08873 ; 8002837866
• MDR Report Key: 4992004
• MDR Text Key: 24073479
• Report Number: 9681834-2015-00183
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: KU
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 08/06/2015,08/11/2015

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: 03/31/2017
• Device Catalogue Number: CX*FX15RW40
• Device Lot Number: 140421
• Is the Reporter a Health Professional?: Yes
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2014
• 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