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

Catalog Number CX-RX05RE

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned to the manufacturing facility for evaluation.Visual inspection with naked eye upon receipt did not find any obvious anomaly, such as a break, in the appearance.Physiological saline solution was flowed through the actual device.Subsequent visual inspection with naked eye did not find any visible clot formation inside the device.The actual device was fixed with glutaraldehyde solution and the housing component was removed for further inspection of the inside of the oxygenator module with the naked eye.No visible clot formation was found.The fiber was found to have been wound in the proper manner.The fiber layer was removed from the winding in increments of 2 mm and each layer was subjected to visual inspection.Red thrombus was found to have formed on the fiber around the heat exchanger module.The outer cylinder was removed and the heat exchanger module was subjected to visual and magnifying inspections.Clots were found to have formed on the bottom and back areas.The fiber layers removed during the test in above were inspected under magnification.The formation of red thrombus was found on the surface of the fiber electron microscopic inspection of the fiber on each layer on the upper side of the fiber winding obtained revealed the formation of fibrin net and the adhesion of red blood cells and echinocytes.The clots formed on the heat exchanger module were collected and electron microscopically inspected.The formation of fibrin net and the adhesion of red blood cells were revealed.Visual inspection of the reservoir did not find any visible anomaly such as a break on it.Red thrombus was found to have formed inside the cr filter.The reservoir was disassembled into each component.The cr filter and the defamer were taken out of the cr filter, after having been rinsed off blood with physiological saline solution, were fixed with glutaraldehyde solution for visual inspection.The formation of red thrombus was found on the outer surface of the cr filter.The segment of the cr filter where the red thrombus had formed was electron microscopically inspected.The formation of fibrin net and the adhesion of red blood cells were revealed.There was no break or clogging on the filter mesh.The venous filter and the defamer were taken out of the venous filter, after having been rinsed off blood with physiological saline solution, were fixed with glutaraldehyde solution for visual inspection.The formation of red thrombus was found inside the venous reservoir.The segment of the venous filter where the red thrombus had formed was electron microscopically inspected.The formation of fibrin net and the adhesion of red blood cells and echinocytes were revealed.There was no break or clogging on the filter mesh.During the above investigation, clot formation was found inside the oxygenator module and the reservoir of the actual device.Electron microscopic inspection of the clots formed inside the actual device revealed the formation of fibrin net and the adhesion of red blood cells and echinocytes.Coincidental occurrences of the factors below could be a cause of reported rise in the solution level in the venous filter, the clot formation and the increased pressure at the inlet port of the oxygenator module.From the available information, however, the definitive cause of this complaint cannot be determined.It is likely that due to the stand-by circulation with priming of blood, transfer of the gas with air led co2 gas to be removed from the priming solution and ph to get raised.Subsequently, administration of meylon (sodium bicarbonate) to the priming solution with increased ph further raised ph.By this red blood cells were degraded into echinocytes, which hindered blood from flowing smoothly.An addition of the priming solution which contained glucose and calcium ion led blood to get coagulated.The device labeling does address the potential for such an event in the instructions-for- use (ifu) with statements such as the following: "avoid a mixed injection of whole blood preparation and/or a red blood cell product with lactic acid loading ringer' solution which contains glucose solution and calcium ion or with a calcium preparation.Mixture of blood with a transfusion preparation which contains calcium ion and/or calcium preparation may cause coagulation and precipitation of fibrin.Mixing of blood with and a glucose solution may cause agglutination of red blood cells and/or erythrolysis due to swelled red blood cells." a review of the device history record of the product/lot number combination was conducted with no relevant findings.A search of the complaint file did not find any other report with the involved product code/lot number combination.(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 clot in the capiox device.Follow up communication with the user facility reported the following information: clots formed during priming plugged the venous filter and the solution level in the venous filter got raised from 70 ml up to 700 ml; the priming time was about 1 hour; the priming solution contained subpack, albumin and rcc (red cell concentrate liquid: 3 units 360 ml); immediately before starting the circulation, meylon, boluben(hes), mannitol and glucose were added; then the solution level in the venous filter started to rise with an increase in the pressure at the inlet port of the oxygenator module; the device was changed out; and there was no harm to the patient.

• 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: 6672584
• MDR Text Key: 78781197
• Report Number: 9681834-2017-00123
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022115
• 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: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: CX-RX05RE
• Device Lot Number: 170127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• 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