FDA.reportPublic FDA data

MAUDE MDR 4907101

MDR report key
4907101
Report number
0001831750-2015-00342
Event key
0
Event type
3
Date of event
2015-07-02
Date received
2015-07-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1B/F WARM SET HIGH FLOW CEDEVICE, WARMING. BLOOD AND PLASMASTRYKER MEDICAL-KALAMAZOOKZLD25330CEN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-07-100

Event Narratives#

D

Patient 1

IT WAS ALLEGED THAT THE MEDITEMP FLUID WARMER CASSETTE RUPTURED DURING USE. IT WAS ALLEGED THE CASSETTE WAS PRIMED IN THE USUAL MANNER WITH NORMAL SALINE AND THEN USED TO INFUSE BLOOD INTO THE PATIENT AS PER HOSPITAL PROTOCOL. THE CASSETTE RUPTURE OCCURRED WHILST THE HOSPITAL STAFF WERE INFUSING BLOOD INTO A PATIENT. IT WAS ALLEGED THE SURGICAL PROCEDURES WERE DELAYED/PROLONGED DUE TO THE THEATRE STAFF HAVING TO LOCATE ANOTHER MEDITEMP BLOOD WARMER AND CASSETTE AND SET UP A NEW BLOOD INFUSION FOR PATIENT. IT WAS ALLEGED THAT PROLONGED RECOVERY TIME FOR PATIENT POST OPERATIVELY, DUE TO DELIVERY OF BLOOD AT LESS OPTIMAL TEMPERATURE.

N

Patient 1

THE INVESTIGATION CONCLUDED THAT A LIKELY CAUSE FOR THIS ISSUE IS USING A PUMP IN SERIES WITH THE DEVICE CREATING A GREATER THAN SPECIFIED PRESSURE WHICH CONTRIBUTED TO THE CASSETTE LEAK.

D

Patient 1

IT WAS ALLEGED THAT THE MEDITEMP FLUID WARMER CASSETTE RUPTURED DURING USE. IT WAS ALLEGED THE CASSETTE WAS PRIMED IN THE USUAL MANNER WITH NORMAL SALINE AND THEN USED TO INFUSE BLOOD INTO THE PATIENT AS PER HOSPITAL PROTOCOL. THE CASSETTE RUPTURE OCCURRED WHILST THE HOSPITAL STAFF WERE INFUSING BLOOD INTO A PATIENT. IT WAS ALLEGED THE SURGICAL PROCEDURES WERE DELAYED/PROLONGED DUE TO THE THEATRE STAFF HAVING TO LOCATE ANOTHER MEDITEMP BLOOD WARMER AND CASSETTE AND SET UP A NEW BLOOD INFUSION FOR PATIENT. IT WAS ALLEGED THAT PROLONGED RECOVERY TIME FOR PATIENT POST OPERATIVELY, DUE TO DELIVERY OF BLOOD AT LESS OPTIMAL TEMPERATURE.