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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORP. SHUNT SENSOR SYS500 BLOOD GAS MONITOR Back to Search Results
Model Number CDI510H
Device Problem Calibration Problem (2890)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Terumo has not received the actual device; therefore, the investigation has yet to be completed. Terumo plans on submitting a follow up report when the investigation is complete and more information becomes available. (b)(4). Results: results pending completion of evaluation. Conclusions: conclusion not yet available-evaluation in progress.
 
Event Description
The user facility reported to terumo cardiovascular that the sensor was not working after calibration. There were no values on display on arterial values. 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 january 11, 2017. (b)(4). The sample was not returned for evaluation. A review of the device history record revealed no manufacturing anomalies. A retention sample from the same product code/ lot number combination was obtained. The retention sample was visually inspected, during which no anomalies were noted. Using the cdi 500 and cdi 540, gas calibration was attempted on the retention sample. The calibration was successful. The sample was then performance tested by linking it within a circuit of buffer solution and reading the output values. No errors were seen during the performance test, and all values were displayed. A definitive root cause could not be determined; therefore, this complaint is not confirmed. 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 CORP.
125 blue ball road
elkton MD 21921
Manufacturer Contact
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key6244204
MDR Text Key64601939
Report Number1124841-2017-00005
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
Type of Report Initial,Followup
Report Date 02/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2017
Device Model NumberCDI510H
Device Catalogue NumberN/A
Device Lot NumberUL26A
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 Received02/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2016
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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