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

Catalog Number CX-RX15E

Device Problem Pressure Problem (3012)

Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

Patient identifier - requested, not provided.Age and date of birth - requested, not provided.Sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Udi number for this product code is not required.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was returned to the manufacturing facility for evaluation.Visual inspection of the actual device found no visible anomalies in the appearance.The actual device was built into a circuit with tubes.Saline solution was filled and circulated in it and the pressure drop was determined at each flow rate.As the result, the pressure drop was found to be comparable to that of the current product.No anomaly was revealed.The actual device was fixed with glutaraldehyde solution and the housing component was removed for further inspection of the inside of the oxygenator module.Any clot formation that was visible with the naked eye was not found.The state of the fiber winding was confirmed to be normal.The fiber layer was removed from the winding in increments of 2 mm and each layer was subjected to visual inspection.There was no clot formation that was visible with the naked eye on the fiber winding.The outer cylinder was removed from the heat exchanger module and the inside of the heat exchanger module was subjected to visual and magnifying inspections.No clot formation was observed.Electron microscopic inspection of the fiber on each layer on the upper side of the fiber winding revealed no formation of clots that could be a trigger of the reported pressure values which were higher than usual.The perfusion record from the involved procedure was reviewed as follows from a view point of customer's complaint on "pressure values higher than usual" and "paco2 value higher than usual.A review of the device history record of the involved product code/lot number combination revealed no relevant findings.A search of the complaint file found no previous report of this nature with the involved product code/lot number combination.Based on the graph from the perfusion record, after the initiation of the circulation at 10:51, the pressure before membrane once increased along with the increase in the centrifugal pump flow rate and became stable.The pressure after membrane increased along with the increase in the centrifugal pump flow rate and became stable.There was no tendency of continued increase seen in the pressure before membrane and that after membrane.There was no decrease in paco2 after the initiation of circulation when compared with that before the initiation of circulation.There was no recorded data d of the gas flow rate.At 10:56, cooling started.A review of the device history record of the involved product code/lot number combination revealed no relevant findings.There is no evidence this event was related to a device defect or malfunction.During the investigation, the pressure drop of the actual sample was verified to be equivalent to that of the current product sample.No obstruction was found.Magnifying inspection of the fiber did not reveal any clot formation in the oxygenator.With no clot formation found in the actual device or no indication in the perfusion record of continued increase in the pressure before membrane, which is the factor to indicate possible obstruction in the oxygenator, it is difficult to determine the cause of the reported pressure higher than usual.As a cause of paco2 higher than usual, cool-down of the patient may have affected the increase in paco2.The lower the blood temperature becomes, the more easily, co2 starts to dissolve in blood and it becomes more difficult to remove the co2 gas from blood at the same gas flow rate.From the available information, however, it is difficult to determine the cause of the reported paco2 higher than usual.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported they noticed at the beginning of the circulation that the pressure was higher than usual.With the blood flow rate at 3.7 l/min, the pressure after membrane was 250 mmhg and the pressure before membrane was 400 mmhg.Expecting the pressure to get decreased, he decided to continue to use the actual device.However, with paco2 which was higher than usual, taking the co2 removal performance and rewarming performance into consideration, he decided to change out the actual device.It was changed out to a rx25 during a pause of circulation.The amount of blood loss is unknown.

• Brand Name: CAPIOX RX 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: 7141594
• MDR Text Key: 95589817
• Report Number: 9681834-2017-00258
• 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: Other
• Type of Report: Initial
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: CX-RX15E
• Device Lot Number: 170712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2017
• 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