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

Catalog Number CX-GE157X

Device Problem Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device was discarded by the involved facility.Based on the reported serial number possible combinations of the oxygenator product code/lot number are listed below: product code: zz*fx15rw40, lot#: 160825, expiration date: july 31, 2019, manufacturing date: august 25, 2016; product code: zz*fx15rw30, lot#: 160824, expiration date: july 31, 2019, manufacturing date: august 24, 2016; product code: zz*fx15rw40, lot#: 160902, expiration date: august 31, 2019, manufacturing date: september 2, 2016.The factory retained samples of these three combinations were respectively evaluated as follows.Visual inspection found no obvious anomalies in the appearance.Each retention sample was built into a circuit with tubes and bovine blood (hct35% and temp.37°c) was circulated in it.The pressure drop was determined at each flow rate.The obtained values were verified to meet manufacturing specifications.No anomalies were confirmed.The provided perfusion record was reviewed.During 8:35:00 - 8:58:40 with the fixed blood flow rate, the pressure drop (dp) kept increasing gradually.At 8:58:12 heparin was administrated, at 8:59:00 the blood flow rate was decreased.Then the pressure drop was decreased from 285mmhg to 242mmhg.After this, the pressure drop started to rise gradually up to max.315mmhg at 9:08:02.During the circulation the temperature was never decreased.Act at 8:35:30 was 905 seconds and at 8:53:09 it was 765 seconds.In spite of the heparin administration at 8:58:12 act was found to have decreased down to 735 seconds at 9:25:27.A review of the potential device history records and the product release decision control sheets was conducted with no relevant findings.A search of the complaint file found no other report with the potential product code/lot number combinations.There is now evidence that this event was related to a device defect or malfunction.The factory retention samples were confirmed to be the normal products.While the exact cause of the reported event cannot be definitively determined based on the available information, the following factor can be inferred as a cause of this complaint.Based on the fact that act started to decrease after the administration of heparin, the patient may be difficult to be act-controlled, e.G.Due to hit or dic, and thrombus was formed in the oxygenator module, resulting in the reported increase in the pressure.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.(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 a pressure increase in the capiox device during a procedure.Follow up communication with the user facility confirmed the following information: after beginning bypass the pressure gradient rose steadily to 315 mmhg with a blood flow of 4.2l /min.; the device was not changed out; the gas exchange was not affected; there was no delay in the procedure; the patient was treated as intended; and (6) 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: 6788977
• MDR Text Key: 83496448
• Report Number: 9681834-2017-00169
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX-GE157X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer 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
• Patient Age: 70 YR
• Patient Weight: 68