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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 Failure to Calibrate (2440)
Patient Problems No Patient Involvement (2645); No Information (3190)
Event Date 09/30/2019
Event Type  malfunction  
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 the shunt sensor would not calibrate. Another calibrator was used to check if it wasn't a calibrator fault which they confirm. It is unknown when the event occurred, whether the product was changed out, whether there was blood loss, if there was any effect on the patient or results of the surgery. Due to the unknown information for this event, it is being reported. Terumo continues to attempt to gain more information regarding this event from the user facility.
 
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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
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key9215850
MDR Text Key164340781
Report Number1124841-2019-00287
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 company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Model NumberCDI510H
Device Catalogue NumberN/A
Device Lot NumberXF06G
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2019
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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