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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 Patient Involvement (2645)
Event Date 11/08/2018
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). Results: results pending completion of evaluation. Conclusions - conclusion not yet.
 
Event Description
The user facility reported to terumo cardiovascular that during prime, a leak was observed after the shunt sensor was attached to the bpm probe in the artery side of the bpm. No patient involvement as this occurred during prime. Product was changed out. Procedure was completed successfully.
 
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 november 29, 2018. (b)(4). All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations. (b)(4). The returned sample was visually inspected, without the sparger assembly. It was leak tested (as received) by connecting with the calibrated manometer, submerged into a water bath, pressurized up to 1030 mmhg. A leak was noted at approximately 20 mmhg. The large bore adapter blue cap was then loosened and re-tightened by hand. It was leak tested for the second time by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg, and no leaks were noted. A retention sample from the same lot number was visually inspected and confirmed to have no traces of buffer on the outside of the unit or inside of the pouch. It was also leak tested and pressurized up to 1030 mmhg. No leaks were noted. The root cause for this event was determined to be the large blue vent cap for shunt sensor was not fully tightened either during setup of the circuit, or after the gas calibration. When the large blue vent cap was loosened, it had not been re-tightened fully prior to use in the line, causing a leak from the cap. 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 road
elkton MD 21921
MDR Report Key8117722
MDR Text Key129060549
Report Number1124841-2018-00310
Device Sequence Number1
Product Code DRY
Combination Product (y/n)N
PMA/PMN Number
K972962
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Model NumberCDI510H
Device Catalogue NumberN/A
Device Lot NumberWF14G
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/10/2019
Is This a Reprocessed and Reused Single-Use Device? No

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