FDA.reportPublic FDA data

MAUDE MDR 710276

MDR report key
710276
Report number
710276
Event key
0
Event type
3
Date of event
2006-04-25
Date received
2006-05-02
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#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PRISMAFLEXCVVHGAMBRO RENAL PRODUCTS, INC.KPFPRISMAFLEX**NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-05-020

Event Narratives#

D

Patient 1

IT APPEARS THAT THE PATIENT RECEIVED A LARGE BOLUS OF HEPARIN. THE MACHINE HISTORY SHOWS THAT THE SET WAS CHANGED FOUR TIMES IN TWENTY-TWO HOURS. ON THE FOURTH SET CHANGE THE MACHINE DID NOT RESPOND TO THE END TREATMENT INSTRUCTION WITH A CORRESPONDING TREATMENT COMPLETE RESPONSE. EACH OF THE OTHER END TREATMENT INSTRUCTIONS, BOTH ON THIS PATIENT AND IN OUR TESTS HAD A CORRESPONDING TREATMENT COMPLETE RESPONSE. THE PATIENT'S PARTIAL THROMBOPLASTIN TIME READINGS WERE 211 SECONDS AFTER THIS EVENT, AND THEY WERE APPROXIMATELY 30 SECONDS TWENTY-FOUR HOURS EARLIER. THERE IS AN INDICATION THAT THE PATIENT ACTUALLY GOT THE EXTRA HEPARIN. THE PATIENT HAD NO ADVERSE RESPONSE TO THE EXTRA MEDICATION. THE MACHINE HAD MANY SYRINGE PUMP ALARMS TOWARDS THE END OF TREATMENT. IN OUR TESTS WE WERE UNABLE TO SILENCE THE SYRINGE PUMP.