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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 11/07/2018
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. For this reason, terumo references evaluation conclusion code (b)(4). Results code: results pending completion of evaluation. Conclusions code: conclusion not yet.
 
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, a leak was observed. 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 dec 2, 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. It was noted to contain dried buffer within the threads of the large bore cap. The returned sample was then leak tested (as received) by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg. No leak was noted. The large blue cap was attempted to be loosened; however, the dried buffer that remained within the threads, left the large bore cap unable to be loosened. The unit was left to soak in di water for 24 hours. The large bore adapter blue cap was then able to 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 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 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 Key8123134
MDR Text Key129048205
Report Number1124841-2018-00311
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 Received12/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Model NumberCDI510H
Device Catalogue NumberN/A
Device Lot NumberWG11D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2018
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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