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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 09/06/2018
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 investigation. Conclusions code: conclusion not yet available.
 
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during out of box, leakage of buffer solution was found when the shunt sensor was unpacked. *no patient involvement as this occurred during out of box.
 
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 september 26, 2018. (b)(4). The returned sample was visually inspected, and was noted to contain dried buffer. The sample was returned without the sparger assembly and without the white cap. The returned sample was leak tested (as received) by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg. No leaks were noted. This was most likely attributed to the dried buffer within the connection threads to the large blue cap. The shunt sensor was then soaked in a di water. The large bore adapter blue cap was then loosened and re-tightened by hand. It was then leak tested the second time by connecting with the calibrated manometer, submerged into a water bath, pressurized up to 1030 mmhg, and a leak was noted from the large blue luer cap at approximately 390 mmhg. The large blue cap was again loosened and re-tightened with calibrated torque wrench to product specification. It was leak tested the third time, and a leak was noted form the large blue luer cap at approximately 550 mmhg. 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 leak tested, pressurized with air up to 1030 mmhg, and no leaks were noted. The complaint was confirmed and the root cause for this event is a lack of sealing between the large bore adapter (blue cap) and the shunt sensor body. When the large blue vent cap is tightened, interference between the threads of the cap and the shunt sensor body exist, causing an inadequate seal leading to a leak. 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 Key7912223
MDR Text Key121867907
Report Number1124841-2018-00237
Device Sequence Number1
Product Code DRY
UDI-Device Identifier00699753160767
UDI-Public(01)00699753160767
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 10/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Model NumberCDI510H
Device Catalogue NumberN/A
Device Lot NumberWE02H
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

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