EM-TEC PEDIATRIC FLOW PROBE 201-30105

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-14 for EM-TEC PEDIATRIC FLOW PROBE 201-30105 manufactured by Thoratec Switzerland Gmbh.

Event Text Entries

[180194600] No further information was provided. A supplemental report will be submitted when the manufacturer? S investigation is completed.
Patient Sequence No: 1, Text Type: N, H10


[180194601] It was reported that there was a flow of 0. 47 lpm when the centrimag (cmag) system was not turned on and there is no flow. The cmag flow probe was connected to a backup cmag system, and the problem continued. The flow probe was then switched with the a different flow probe with the same console. This resolved the issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916596-2020-00838
MDR Report Key9713050
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-02-14
Date of Report2020-02-14
Date of Event2020-01-27
Date Mfgr Received2020-01-27
Date Added to Maude2020-02-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. BOB FRYC
Manufacturer Street6035 STONERIDGE DRIVE
Manufacturer CityPLEASANTON CA 94588
Manufacturer CountryUS
Manufacturer Postal94588
Manufacturer Phone7818528204
Manufacturer G1THORATEC SWITZERLAND GMBH
Manufacturer StreetTECHNOPARKSTRASSE 1
Manufacturer CityZURICH CH-8005
Manufacturer CountrySZ
Manufacturer Postal CodeCH-8005
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEM-TEC PEDIATRIC FLOW PROBE
Generic NameCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Product CodeDWA
Date Received2020-02-14
Model Number201-30105
Catalog Number201-30105
Lot Number6480352
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTHORATEC SWITZERLAND GMBH
Manufacturer AddressTECHNOPARKSTRASSE 1 ZURICH CH-8005 SZ CH-8005


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-14

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