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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 Consequences Or Impact To Patient (2199)
Event Date 10/24/2018
Event Type  malfunction  
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).
 
Event Description
The user facility reported to terumo cardiovascular that after cardiopulmonary bypass, a leak was observed from the shunt sensor. No consequences or impact to patient. Product was not 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 12, 2018. (b)(4). The returned sample was visually inspected. It was noted to contain dried blood within the threads of the large bore cap. It was then leak tested (as received) by connecting with the calibrated manometer, submerged into a water bath, and pressurized with air. A leak was noted from the large bore adapter cap at approximately 90 mmhg. The large blue cap was then loosened and re-tightened by hand. The sample was then leak tested a second time by connecting with the calibrated manometer, submerged into a water bath, and pressurized with air. A leak was noted form the large bore adapter cap at approximately 160 mmhg. The cap was loosened and re-tightened by hand a second time then leak tested again by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg. No leaks were noted. The second leak after loosening and re-tightening the first time is most likely attributed to dried blood remaining within the threads creating a void in the seal. The dried blood was most likely loosened and removed during the second loosening and re-tightening prior to the third leak test. 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 the pouch. The retention sample was then pressurized with air up to 1030 mmhg, submerged in a water bath, and observed for any leaks. No leaks were noted on the retention sample. 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 Key8062629
MDR Text Key128055723
Report Number1124841-2018-00289
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
Report Date 12/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model NumberCDI510H
Device Catalogue NumberN/A
Device Lot NumberWD12
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

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