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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION H/S CUVETTE 3/8X3/8-JAPAN BLOOD GAS MONITOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION H/S CUVETTE 3/8X3/8-JAPAN BLOOD GAS MONITOR Back to Search Results
Model Number CV-6913
Device Problem Leak/Splash (1354)
Patient Problems Injury (2348); Blood Loss (2597)
Event Date 02/07/2020
Event Type  Injury  
Manufacturer Narrative
Terumo has received the device for evaluation; however, 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, a blood leak was noted. Per user facility the cuvette was set to a cdi probe. When about one hour passed after the procedure started, blood leakage from the cuvette was observed. After the cdi probe was removed, a transparent tape was used to fix it. After that, no blood leakage or suction of bubbles was observed, and the procedure was continued. Percutaneous cardiopulmonary support (pcps) was used in the cardiac catheterization laboratory. After the procedure, the patient was transferred to the icu, and then a cdi500 system was used. The patient expired at a later date, on (b)(6) 2020.
 
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Brand NameH/S CUVETTE 3/8X3/8-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 Key9776695
MDR Text Key188529534
Report Number1124841-2020-00048
Device Sequence Number1
Product Code DRY
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 04/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2022
Device Model NumberCV-6913
Device Catalogue NumberN/A
Device Lot NumberXC11
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/11/2018
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: 03/02/2020 Patient Sequence Number: 1
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