MAUDE MDR 710270

MDR report key
710270
Report number
710270
Event key
0
Event type
3
Date of event
2006-04-24
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
1PRISMAFLEXDIALYSIS MACHINE, CVVHGAMBRO RENAL PRODUCTS, INC.KPFPRISMAFLEX60230114700*NY

Patients#

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

Event Narratives#

D

Patient 1

THIS EVENT INVOLVED WHAT THE MANUFACTURER REFERRED TO AS A HISTORY JUMP, WHICH INVOLVED SOME ERRORS AND SUBSEQUENT ERRONEOUS VOLUME READINGS. THE NURSE HAD CHANGED THE PATIENT SET AND GOT A CLAMPED BAG ALARM AND A BAG WEIGHT ALARM SHORTLY THEREAFTER. THE HISTORY LOGGED IN THE MACHINE CONFIRMED THIS. THE MACHINE CONTINUOUSLY TAKES WEIGHT READINGS ON ALL BAGS AND GIVES FLOW READINGS AND VOLUME READINGS THAT DIRECTLY CORRELATE TO THOSE WEIGHT READINGS. NURSING EDUCATION WAS CALLED TO THE MACHINE AND SAW THAT PATIENT'S FLUID REMOVAL READINGS WERE FAR BEYOND ACCEPTABLE PARAMETERS. THE MACHINE WAS SHUT DOWN. SHE CHECKED THE PATIENT VITALS AND THAT CHECK SHOWED THAT THE PATIENT SHOWED NO ILL EFFECTS FROM THE FALSE FLUID REMOVAL READINGS. THE MACHINE WAS REMOVED FROM SERVICE AND WE WERE CALLED TO CHECK THE MACHINE. WE CALLED THE MANUFACTURER. THE SERVICE REPRESENTATIVE SHOWED THE NEXT DAY TO CALIBRATE THE SCALES AND WE REVIEWED THE EVENT HISTORY LOGS. THE HISTORY SHOWS THAT THE FLOW AND VOLUME READINGS WERE PROGRESSING AT ACCEPTABLE RATES UNTIL THE CLAMPED BAG ALARMED AT 5:59 AM AND THE BAG WEIGHT ALARMED AT 6:00 AM. THE READINGS AT 6:00 SHOWED SHARP SPIKES. AT 6:01 THE READINGS WERE ON THERE WAY BACK TO NORMAL AND WERE COMPLETELY NORMAL BY 6:03 AM. WE WERE ABLE TO REPRODUCE SEVERAL HISTORY JUMPS, BAG ALARMS AND ASSOCIATED SPIKE FLOWS AND VOLUMES BY SIMPLY LIFTING THE BOTTOM OF THE BAG WHILE THE MACHINE IS RUNNING. IT TOOK FOUR SECONDS OF CONTACT WITH THE BAG TO PRODUCE AN ALARM. THE MANUFACTURER SAID THEY HAVE HAD PREVIOUS HISTORY JUMPS AND WERE WORKING ON THE ISSUE.