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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 Blood Loss (2597)
Event Date 10/02/2018
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 during cardiopulmonary bypass, there was a leakage of blood out of the dots on the shunt sensor. There is a few ml of blood loss. The product was changed out. Procedure 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 oct 19, 2018. (b)(4). The returned sample was visually inspected. The sparger assembly and white cap were not returned with the sample. Additionally, the large bore adapter blue cap was not seated fully on the device. The returned sample was then leak tested (as received) by connecting with the calibrated manometer, submerged into a water bath, and pressurized. A leak was noted at 9 mmhg. The large bore adapter blue cap was then loosened and re-tightened by hand. The sample was then leak tested by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg, and no leaks were noted. The first leak was most likely attributed to the loose cap, as received. A retention sample of the same product code and lot number combination was visually inspected, and no visual anomalies were noted. The retention sample was also leak tested up to 1030 mmhg, and no leaks were noted. The root cause for this event may have been the large blue vent cap for the 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 may not have been re-tightened fully prior to use in the line, causing 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 Key7986646
MDR Text Key124501800
Report Number1124841-2018-00263
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 11/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2018
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 NumberWE23F
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/28/2018
Is This a Reprocessed and Reused Single-Use Device? No

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