MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 1CX*FX05RW

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Udi number - due to the lot number for the involved device being unknown only the di section of the udi number has been provided.The actual device was not returned to the manufacturing facility for evaluation.Therefore the investigation was based upon the information provided by the user facility and review of quality documents.A meaningful review of the device history record and product release decision control sheet of the involved product code could not be conducted due to the lot number being unknown.A search of the complaint file found 3 other complaints of this nature have been reported from the same user facility.See mdr numbers 9681834-2017-00132, 9681834-2017-00139 and 9681834-2017-00140.The exact cause of the reported event cannot be definitively determined based on the available information, it is likely air may have entered the oxygenator module or during priming air may have remained in the oxygenator module resulting in the reported event.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following.- when capiox fx05 oxygenator module is used separately from the hard-shell 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.- 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.- do not obstruct gas outlet port.Avoid buildup of excess pressure in the gas phase to prevent gaseous emboli entering the blood phase.- pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase.- the gas flow rate should not exceed 5 l/min.Excessive gas flow rate will bring about pressure increase in the gas phase, allowing gaseous emboli to enter the blood phase.- 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.- 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 0.5 l/min.- make sure the circuit and the purge line are not clamped, then start pump at a low speed.After checking for leakage or any other problem, gradually increase flow above 0.5l/min, but do not exceed 1.5l/min.Vigorously recirculate the priming fluid through the entire circuit until all air bubbles are eliminated.After all air bubbles are eliminated, circulate at full flow for 10 min.To check oxygenator and tubing for leakage or any other problem.(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 the air bubble detector going off in the capiox device during a procedure.Follow up communication with the user facility confirmed the following information: the procedure conducted was a cardiopulmonary bypass; the air bubble detector was going off and they had to air was purged from the arterial line; a roller head was used and prime was pumped through the oxygenator; the product was not changed out, the case was continued by purging air from the arterial line; the procedure was completed; the customer was not able to give an exact date of event but reported that this event had happened within the last 90 days; and there was no reported problem with the patient.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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; 418 ; JA 418
• Manufacturer Contact: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6711267
• MDR Text Key: 80034175
• Report Number: 9681834-2017-00141
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: 04987350781772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2017

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 Catalogue Number: 1CX*FX05RW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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