FDA.reportPublic FDA data

MAUDE MDR 5407929

MDR report key
5407929
Report number
0001831750-2016-00023
Event key
0
Event type
3
Date of event
2016-01-04
Date received
2016-02-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. BRIAN THOMPSON
Address
3800 EAST CENTRE AVENUE PORTAGE MI 49002 US
Phone
269-269-2693
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CAPITAL BLOOD/FLUID WARMERDEVICE, WARMING. BLOOD AND PLASMASTRYKER MEDICAL-KALAMAZOOKZLFW603N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-02-030

Event Narratives#

D

Patient 1

THE CUSTOMER REPORTED A TEMPERATURE CONTROL ISSUE WITH THE FLUID WARMER. THEY FURTHER REPORTED THAT THE TEMPERATURE THAT THE MACHINE WAS WARMING TO WAS APPROXIMATELY 47 DEGREES CELSIUS, WHICH APPEARED TO EXCEED THAT WHICH WAS STATED BY THE MACHINE 42 DEGREES CELSIUS. THIS WAS NOTICED BY STAFF WHO WHERE OBSERVING THAT THE MACHINE WAS RUNNING AT A HIGHER TEMPERATURE THAN IT WAS SET TO. THE MACHINE WAS IMMEDIATELY SWITCHED OFF AND ANOTHER MACHINE FROM THE FLEET WAS USED INSTEAD. THERE WERE NO ADVERSE CONSEQUENCES OR INJURY FOR THE PATIENT.

N

Patient 1

THE DEVICE WAS EVALUATED AND REPAIRED BY A THIRD PARTY REPAIR FACILITY.

D

Patient 1

THE CUSTOMER REPORTED A TEMPERATURE CONTROL ISSUE WITH THE FLUID WARMER. THEY FURTHER REPORTED THAT THE TEMPERATURE THAT THE MACHINE WAS WARMING TO WAS APPROXIMATELY 47 DEGREES CELSIUS, WHICH APPEARED TO EXCEED THAT WHICH WAS STATED BY THE MACHINE 42 DEGREES CELSIUS. THIS WAS NOTICED BY STAFF WHO WHERE OBSERVING THAT THE MACHINE WAS RUNNING AT A HIGHER TEMPERATURE THAN IT WAS SET TO. THE MACHINE WAS IMMEDIATELY SWITCHED OFF AND ANOTHER MACHINE FROM THE FLEET WAS USED INSTEAD. THERE WERE NO ADVERSE CONSEQUENCES OR INJURY FOR THE PATIENT.