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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX25RWC
Device Problem Free or Unrestricted Flow (2945)
Patient Problems Cardiac Arrest (1762); Injury (2348); Blood Loss (2597)
Event Date 07/24/2018
Event Type  Injury  
Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed. Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available. (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, air bubbles were noticed at the hard shell reservoir outlet. As they attempted to refill the patient by the cardioplegia circuit, unpriming of the oxygenator, the patient received an air bubble into the aorta. The arterial pump was put on stand alone mode, filled the patient and restarted the ecc. The user facility identified the issue at the venous hardshell outlet (as the tie band rotated instead of being well tightened). A tie band was added on the outlet connector and the procedure was complete. The patient had cardiac arrest then convulsions few hours after the operation. The patient had woken up and was oriented but with hemiplegia. Blood loss amount is unknown, product was not changed out, procedure was completed successfully.
 
Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on august 21, 2018. (b)(4). The returned sample was inspected and set into a circuit and flowed at approximately 5 l/min, the sample did not show any tendency for air bubbles to reach the patient, which is to be expected as the additional complaint details explain that the issue was fixed during the case. The tube connected to the reservoir outlet port was noted to be extremely loose and the tie band was not cinched enough to properly hold the connection at the reservoir outlet port. The tubing was easily shifted up and down the reservoir outlet port. As the tubing was shifted lower off the port, air was noticed to be sucked into the circuit, confirming the complaint. The root cause of this issue is a poor connection between the tubing and the reservoir outlet port, including a tie band not properly fixed onto the tubing. This connection is made by the terumo tubing pack manufacturer. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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Brand NameSTERILE FX25RWC W/ RES
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball road
elkton MD 21921
MDR Report Key7800685
MDR Text Key117704478
Report Number1124841-2018-00185
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier00699753450837
UDI-Public(01)00699753450837
Combination Product (y/n)N
PMA/PMN Number
K151791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2020
Device Model Number3CX*FX25RWC
Device Catalogue NumberN/A
Device Lot NumberVP18 OR WA01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/28/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/21/2018 Patient Sequence Number: 1
Treatment
TUBINGPACK (2CXFR265X); TUBINGPACK(2CXFR265X)
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