MAUDE MDR 2039513

MDR report key
2039513
Report number
1221826-2011-00013
Event key
0
Event type
3
Date of event
2011-02-18
Date received
2011-03-24
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#

Address
91 CARPENTER HILL RD. CHARLTON MA 01507 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KARL STORZCONTINUOUS FLOW PUMPKARL STORZ ENDOVISIONKQT27224P27224PNAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-03-2401. O

Event Narratives#

D

Patient 1

ALLEGEDLY, AT THE BEGINNING OF A TURBT PROCEDURE, DOCTOR NOTICED PUMP WAS NOT SUCTIONING WELL AND SOME BROWNISH LIQUID WAS BACKING UP IN THE PT. AT THAT TIME, THEY EXAMINED PUMP AND DISCOVERED THAT SOMEONE IN THE OPERATING ROOM STAFF HAD REVERSED THE TUBING WHEN THEY ASSEMBLED ON THE PUMP. THEY PUT THE SUCTION END INTO A SURGICAL DRAIN AND SOME MATERIAL WAS PUMPED INTO PT. DOCTOR ABORTED PROCEDURE. AS A PRECAUTION, THEY PUT PT ON COURSE OF ANTIBIOTICS AND CONTACT SAID THERE WERE NO ADVERSE EFFECTS ON THE PT NOTED AS A RESULT OF THIS EVENT. DUE TO PT'S UNDERLYING MEDICAL CONDITION, HE WAS REFERRED TO ANOTHER HOSPITAL FOR THE TURBT PROCEDURE. THERE WAS NO REPORT OF MALFUNCTION.

N

Patient 1

THE UNIT WAS NOT RETURNED BECAUSE THE HOSPITAL REPORTED IT DID NOT MALFUNCTION; THEY PUT IT BACK INTO CIRCULATION. OUR USER INSTRUCTION MANUAL FOR THE CONTINUOUS FLOW PUMP HAS WARNINGS THAT STATE: CAUTION: THE (B)(4) IS DESIGNED AS A LOW TO MEDIUM FLOW SUCTION PUMP FOR LIQUIDS ONLY. THIS PUMP IS NOT TO BE USED AS AN INFUSION PUMP, I.E., TO PUMP LIQUID OR GAS INTO THE PT. CAUTION: IT IS EXTREMELY IMPORTANT THAT THE TUBING BE PROPERLY CONNECTED IN THE CORRECT DIRECTION THROUGH THE PUMP HEAD. IF THE DIRECTION OF THE FLOW IS REVERSED, THE OUTPUT OF THE PUMP WILL BE INTO THE PT WHICH IS EXTREMELY DANGEROUS. ON THE PUMP ITSELF, THE INFLOW/OUTFLOW IS CLEARLY MARKED IN BRIGHT YELLOW AND BLACK DIRECTIONS ALONG WITH ARROWS SHOWING THE CORRECT DIRECTION/ORIENTATION WHEN INSTALLING TUBING.