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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 Problem No Information (3190)
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 does not calibrate. It is unknown when this event occurred, whether the product was changed out, or 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.
 
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 (b)(6) 2018. Upon further investigation of the reported event, the following information is new and/or changed: additional device information - added exp date, date received by manufacturer, indication that this is a follow-up report, follow-up due to additional information, device manufacture date. The actual sample was not returned for evaluation. However, a retention sample from the affected product code/lot number was obtained and visually inspected, no anomalies were noted. Gas calibration was attempted and successfully able to pass the calibration without any issues. The reported event could be replicated and the actual root cause cannot be determined. Potential root causes for the calibration error include opening the pouch more than 24 hours prior to calibration, contaminated buffer solution, or damage or mishandling of the shunt sensor. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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Brand NameSHUNT SENSOR SYS500
Type of DeviceBLOOD GAS MONITOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball rd
elkton MD 21921
Manufacturer Contact
cathleen hargreaves
125 blue ball rd
elkton, MD 21921
8002837866
MDR Report Key7481247
MDR Text Key107216742
Report Number1124841-2018-00075
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Model NumberCDI510H
Device Catalogue NumberN/A
Device Lot NumberWA22C
Other Device ID Number(01)00699753160767
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/14/2018
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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