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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 07/03/2018
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 setup, when the shunt sensor was being unpacked, a leak was found.No patient involvement as this occurred during setup; 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 july 30, 2018.(b)(4).Upon completion of the investigation, the event is confirmed.The sample was visually inspected, there was no buffer solution in the device.No other visual anomalies were noted.The unit was pressurized with air up to 1030 mmhg, submerged in a water bath, no leaks were noted within the device.The large blue cap was then loosened and retightened with a calibrated torque wrench to production specification.The unit was then pressurized with air, submerged in a water bath, a leak was noted from the large blue luer cap at approximately 220 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 then pressurized with air, submerged in a water bath, a leak was noted at approximately 700 mmhg.The cap was loosened and retightened with a calibrated torque wrench to production specification.The unit was then pressurized with air, submerged in a water bath, a leak was noted from the large blue luer cap at approximately 550 mmhg.The complaint was confirmed and the root cause for this event is a lack of sealing between the large bore adapter 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.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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Brand Name
SHUNT SENSOR SYS500
Type of Device
BLOOD GAS MONITOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball road
elkton MD 21921
MDR Report Key7732643
MDR Text Key115473137
Report Number1124841-2018-00165
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 08/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2018
Device Model NumberCDI510H
Device Catalogue NumberN/A
Device Lot NumberWA15A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/11/2018
Initial Date FDA Received07/30/2018
Supplement Dates Manufacturer Received08/06/2018
Supplement Dates FDA Received08/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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