HEATER-COOLER UNIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-16 for HEATER-COOLER UNIT manufactured by Unk.

Event Text Entries

[133553468] A (b)(6) y/o with cad s/p cabg in 2008; mv repair on (b)(6) 2016 done at outside hospital (with annuloplasty and gortex valvuloplasty). Now diagnosed disseminated mycobacterium chimaera. Suspected contamination from heater-cooler unit during mv repair in 2016.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5083203
MDR Report Key8257067
Date Received2019-01-16
Date of Report2019-01-11
Date Added to Maude2019-01-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHEATER-COOLER UNIT
Generic NameHEATER-COOLER UNIT
Product CodeILO
Date Received2019-01-16
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention 2019-01-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.