BIOMEDICUS NONE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-04 for BIOMEDICUS NONE * manufactured by Medtronic Bio-medicus, Inc..

Event Text Entries

[20840] After one hour into open-heart surgery procedure, perfusionist noticed large bolus of air from venous reservoir to pump head. Tubing clamped off, air eliminated but when turning pump back on, it failed to start. Replaced with second pump.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number35678
MDR Report Key35678
Date Received1996-08-15
Date of Report1996-08-06
Date of Event1996-08-05
Date Facility Aware1996-08-05
Report Date1996-08-06
Date Added to Maude1996-08-22
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBIOMEDICUS
Generic NamePUMP
Product CodeHQY
Date Received1996-09-04
Model NumberNONE
Catalog Number*
Lot NumberNONE
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key37106
ManufacturerMEDTRONIC BIO-MEDICUS, INC.
Manufacturer Address9600 WEST 76TH ST EDEN PRAIRIE MN 55344 US
Baseline Brand NameRAY-BAN SUNGLASSES
Baseline Generic NameSUNGLASSES
Baseline Model NoMULTIPLE
Baseline Catalog NoVARIOUS
Baseline IDNONE
Baseline Device FamilySUNGLASSES
Baseline Shelf Life Contained*
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentY
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 1996-08-15

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