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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SHUNT SENSOR SYS500 BLOOD GAS MONITOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SHUNT SENSOR SYS500 BLOOD GAS MONITOR Back to Search Results
Model Number CDI510H
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2022
Event Type  malfunction  
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the shunt sensors have been leaking. No patient involvement. Product was changed out. Procedure was completed successfully.
 
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).
 
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Brand NameSHUNT SENSOR SYS500
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
jamie quinlan
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key13763647
MDR Text Key289878048
Report Number1124841-2022-00044
Device Sequence Number1
Product Code DRY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972962
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Followup
Report Date 04/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCDI510H
Device Catalogue NumberN/A
Device Lot NumberZK16C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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