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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 08/20/2018
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. For this reason, terumo references evaluation conclusion. (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, a leakage was found from the shunt sensor. 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 september 7, 2018. (b)(4). The returned sample was visually inspected with no anomalies noted. The unit was then pressurized with air (as received) up to 1030 mmhg, submerged in a water bath, and no leak were noted. The large blue cap was then loosened and retightened with a calibrated torque wrench to production specification, it was then pressurized with the 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 leak tested, pressurized up to 1030 mmhg. A leak was observed from the large bore cap after approximately 5 seconds. The root cause for the retention sample leak 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 inadequate seal leading to a leak. However, 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 Key7857490
MDR Text Key119651353
Report Number1124841-2018-00221
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 10/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/07/2018
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 NumberWE16C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/22/2018
Is This a Reprocessed and Reused Single-Use Device? No

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