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

Catalog Number ZZ*FX15RW40

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2017

Event Type  Injury  

Manufacturer Narrative

The actual device was returned for evaluation.Visual inspection found no anomalies which would relate to a gas leak or insufficient gas transfer performance.The retention sample was tested for its gas transfer performance in accordance to the factory's shipping inspection protocol.Bovine blood arranged to was circulated in the oxygenator module under the following conditions: @ v/q=1, fio2=100% and the flaw rate of 6 l/min.And 4 l/min.Result: o2 transfer: @ 6 l/min.= 403 ml/min.@ 4 l/min.=281 ml/min.Co2 removal: @ 6 l/min.= 320 ml/min.@ 4 l/min.= 247 ml/min.No anomalies were revealed in the gas transfer performance of the retention sample, with the obtained values meeting the factory specification.Review of the pump record from the involved procedure obtained the information as follows.The initial pco2 value indicated on the pump record was 50.7 mmhg.Ten (10) minutes after the initiation of the circulation, the blood flow rate was 4.0 l/min.And the gas flow rate was 2 l/min.Subsequent values before the actual sample was changed out 108 minutes after the initiation of the circulation.An increase in the gas flow rate led to a decrease in pco2.With the assumption that the numbers indicated on the left side of the slash are the values of pco2s in the arterial blood, pco2s in the arterial blood were noted to have become lower than that in the venous blood.After starting circulation (min.): 15, blood flow rate: 4.3 l/min, gas flow rate: 3 l/min, paco2: 44/51.3; 26, 4.0 l/min, 3.8 l/min, 30, 4.1 l/min, 3.5 l/min, 45, 4.2 l/min, 3.5 l/min, 40/47; 60, 4.3 l/min, 3.7 l/min, 75, 4.3 l/min, 4 l/min, 43/48.3; 94, 4.3 l/min, 5.5 l/min.A review of the device history record and product release decision control sheet of the involved product code/lot number combination was conducted with no relevant findings.A search of the complaint file found no other complaints of this nature with the product code/lot number combination.There is no evidence this event was related to a device defect of malfunction.The investigation result verified the retention sample was the normal product with no issue in the gas transfer performance.While the exact cause of the reported event cannot be definitively determined based on the available information, it is likely the wet lung phenomenon had occurred and moisture had been generated.Due to this the contact between the gas and blood was hindered resulting in the reported difficulty in oxygenation.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: do not reduce heparin during circulation.Otherwise, blood clotting might occur.Adequate heparinization of the blood is required to prevent it from clotting in the system." start gas supply with v/q =1 and fio2=100%, then make adjustments based on blood gas measurements.Measure blood gases and make necessary adjustments as follows.Control paco2 by changing total gas flow.To decrease paco2, increase total gas flow.To increase paco2, decrease total gas flow.(b)(4).

Event Description

The user facility reported co2 transfer failed when using the involved capiox device.Follow up communication with the user facility confirmed the following information: the oxygenator was changed successfully.There was no harm to the patient.

• Brand Name: CAPIOX FX OXYGENATOR
• 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; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 7006981
• MDR Text Key: 91248974
• Report Number: 9681834-2017-00237
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K071494
• 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: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: ZZ*FX15RW40
• Device Lot Number: 161212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 80