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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 09/19/2018
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).
 
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, while the shunt sensor was being unpacked, a leak was found. 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 october 8, 2018. 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 with no anomalies noted. The unit was pressurized with air (as received) up to 1030 mmhg, submerged in a water bath, and no leak was noted. The large blue cap was then loosened and retightened with a calibrated torque wrench to production specification, it was then pressurized with air, submerged in a water bath. No leak was 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. It was then pressurized with air, submerged in a water bath, and no leaks were noted. The complaint was not confirmed, and a definitive root cause was not able to be determined. It is possible that the buffer solution was not completely wiped off the product after buffer fill during manufacturing. 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 Key7944620
MDR Text Key123362097
Report Number1124841-2018-00250
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 11/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2018
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 NumberWE09
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/29/2018
Is This a Reprocessed and Reused Single-Use Device? No

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