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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 09/14/2018
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, during prime, a leak on the connection part of the shunt sensor was observed. No patient involvement. 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 october 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. A leak was noted from the large bore adaptor at approximately 23 mmhg. The large blue cap was then loosened and retightened by hand. The unit was then pressurized with air, submerged in a water bath, and observed for any leaks. A leak was noted again from the large blue luer cap at approximately 120 mmhg. The shunt sensor was then soaked in di water. After loosening and re-tightening the blue large bore adapter a second time (removing/loosening dried buffer residue), the sample was leak tested again by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg, and no leaks were noted. The second leak was most likely attributed to dried buffer within the threads of the sensor connections that was not fully removed during decontamination. Decontamination is originally done less aggressively to maintain sample integrity for testing as received by the returning facility. 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 observed for any leaks, pressurized with air up to 1030 mmhg. No leaks were noted. 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 Key7928222
MDR Text Key122457994
Report Number1124841-2018-00248
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 Received10/02/2018
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 NumberWE23G
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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