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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX-FX15W
Device Problem Connection Problem (2900)
Patient Problem Blood Loss (2597)
Event Date 06/13/2018
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. 510(k): k130520. The actual device has been returned for evaluation. Visual inspection upon receipt did not find any anomaly in the visual appearance of the blood cardioplegia port, such as a break. The competitor's tube involved in this complaint was not provided for us for evaluation. The actual device was rinsed and dried. The outside diameter of the blood cardioplegia port was determined and verified to be equivalent to that of the factory-retained sample of the involved product code. A factory-retained 1/4-inch elastic/soft tube was connected to the blood cardioplegia port. The blood phase was filled with saline solution, where an inner pressure of approx. 1000mmhg was applied. No leak at the joint between the port and the tube or no coming-off of the tube from the port occurred/ at the joint. The reproductive tests below were performed on the actual device. In the test no tie-band was applied to the joint of the tube and the blood cardioplegia port based on the idea that if the tube would not come off the port with no application of a tie-band to their joint, then with an application of a tie-band, the tube would not come off the port. A factory-retained 1/4-inch elastic/soft tube was connected to the blood cardioplegia port. With the tube clamped, saline solution was circulated in the actual device at the back pressure of 200mmhg. The tube was confirmed not to come off the port. The clamp on the tube was released. The tube was confirmed not to come off the port. Subsequently, with the application of the back pressure of 200mmhg still kept, the tube was subjected to pulling force by being pulled by a hand in the direction of pulling off the tube. The tube was confirmed not to come off the port. The tube jointed to the port was further pushed to let it go over the barb on the port and saline solution was circulated in the actual device at the back pressure of 200mmhg. A leak was noted at the joint but the tube would not come off the port. After the test result; with a leak at the joint, the tube was subjected to pulling force by being pulled by a hand in the direction of pulling off the tube. A possibility that the tube may come off the port was revealed. It is likely that the leaked saline solution seeped into the joint between the tube and port and acted as a lubricant. Ifu reference: regularly check all tubing connections and ports for looseness or leakage. Ensure that all connected parts including the luer caps, the lock adapters and the port caps, are securely affixed. Loose connections may cause contamination or a blood leak. A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed no findings. The complaint file was searched back for the past ten years for any similar report. There has been no report of coming off of a tube connected to the blood cardioplegia port on a fx15 oxygenator module to date. There is no evidence that this event was related to a device defect or malfunction. Based on the investigation result, it is likely that blood seeped into the joint between the competitor's tube and the blood cardioplegia port of the actual device and acted as a lubricant when the tube was subjected to pulling force due to some factor, resulting in the tube coming off the port. With the absence of the competitor's tube for evaluation, the exact cause of the reported event cannot be definitively determined based on the available information. (b)(4).
 
Event Description
The user facility reported a connection failure with the involved capiox fx oxygenator. Before weaning the patient off the extracorporeal circulation, in order to collect blood contained in the cardioplegia circuit, the customer unclamped the blood cardioplegia port, when the tube connected to the blood cardioplegia port came off. The back pressure was approximately 200mmhg. The joint of the tube and port had been tie-banded firmly. Immediately after the tube having come off, the customer stopped the pump and applied forceps within 20 seconds. The amount of blood loss and the procedure outcome was unknown. The patient was reported to be getting better.
 
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Brand NameCAPIOX FX OXYGENATOR
Type of DeviceOXYGENATOR, 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
950 elkton blvd
elkton, MD 21921
MDR Report Key7666173
MDR Text Key113307052
Report Number9681834-2018-00118
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier04987350701183
UDI-Public04987350701183
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Catalogue NumberCX-FX15W
Device Lot Number180202
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/06/2018 Patient Sequence Number: 1
Treatment
CENTRIFUGAL PUMP (SENKO MEDICAL INSTRUMENT); TUBE FOR THE CIRCUIT (SENKO MEDIAL INSTRUMENT)
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