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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION H/S CUVETTE 1/4X1/4-JAPAN BLOOD GAS MONITOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION H/S CUVETTE 1/4X1/4-JAPAN BLOOD GAS MONITOR Back to Search Results
Model Number CV-6914
Device Problem Leak/Splash (1354)
Patient Problems Death (1802); Blood Loss (2597)
Event Date 06/26/2020
Event Type  Death  
Manufacturer Narrative
The returned sample was visually inspected for damage in the weld area that would be indicative of a leak, and no damage was noted. The unit was left to soak in a bleach solution for 15 minutes in efforts to remove as much of the blood as possible without damaging the unit. It was then pressurized to 15. 0 psi with air and submerged in a water bath to detect any possible leaks. The pressure was then increased to approximately 19-20 psi (maximum pressure per the ifu), and the unit began to leak during this test, immediately. The probe was then detached and submerged in water; however, the leak stopped upon the detachment. It could be seen that bubbles were formed along the weld channel of the unit after detachment indicating that the leak was from the corner of the weld near the hoop; where the dried blood was found upon receipt of the sample. A retention sample from the same product code and lot number was evaluated using the same test method, and no visual damage on the weld or barb area and no leak when pressurized with air and submerged in a water bath was observed. (b)(4). All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
 
Event Description
The user facility reported to terumo cardiovascular that during extracorporeal membrane oxygenation (ecmo), blood leakage from the cuvette was observed. On (b)(6) 2020 around noon, ecmo was started. On (b)(6) 2020 at 10:50am, the circuit was changed and the reported cuvette was used. On (b)(6) 2020 at 9am, air was observed in the upper part of the lung. After air was removed, there was still air in the lung. Then, blood leakage from the cuvette was observed, it was changed out and no other blood leak was observed. The cuvette had been used for 22 hours on ecmo prior to the unit presenting a leak. A solution called intralipos was administered from the left groin using v-vecmo with venous line from the left internal carotid artery and arterial line from the right groin. The patient had leukemia and developed pulmonary failure. Mechanical ventilator and ecmo were initiated. It was planned that the patient would be transferred for lung transplantation. However; before transfer happened, cerebral edema, cerebral hemorrhage and brain tumor occurred, and eventually the patient expired. Product was changed out. Blood loss of a few ml. Procedure was completed successfully; however, the patient expired at a later date.
 
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Brand NameH/S CUVETTE 1/4X1/4-JAPAN
Type of DeviceBLOOD GAS MONITOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball road
elkton MD 21921
Manufacturer (Section G)
SAME
Manufacturer Contact
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key10282279
MDR Text Key199053401
Report Number1124841-2020-00162
Device Sequence Number1
Product Code DRY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K915265
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2021
Device Model NumberCV-6914
Device Catalogue NumberN/A
Device Lot NumberWL03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2018
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: 07/16/2020 Patient Sequence Number: 1
Treatment
CENTRIFUGAL PUMP 560 (MEDTRONIC); CIRCUIT (SENKO MEDICAL INSTRUMENT); ECMO (BIOCUBE4000, NIPRO)
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