MAUDE MDR 242079

MDR report key
242079
Report number
1719891-1999-00015
Event key
0
Event type
3
Date of event
1999-07-19
Date received
1999-09-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
E. CHAMBERLAIN, PHD
Address
12050 LONE PEAK PKWY DRAPER UT 84020 US
Phone
801-801-8015
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SAFETY DRAINCLOSED CIRCUIT DRAINBYHK881790YRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11999-09-2401. D

Event Narratives#

D

Patient 1

IN 1999 A CARDIOPULMONARY TECH WAS ATTEMPTING TO SUCTION CONDENSATE FROM A SAFETY DRAIN THAT WAS CONNECTED TO A BEAR III VENTILATOR. THE PT WAS A 49-YR-OLD MALE WITH END STAGE RENAL DISEASE. THE SAFETY DRAIN WAS PLACED BETWEEN THE MAIN EXPIRATORY VALVE MIDWAY IN THE CIRCUIT AND THE ONE WAY CHECK VALVE THAT CONNECTS ON TOP OF THE FLOW SENSOR TUBE. THIS ONE WAY VALVE NORMALLY REMAINS CLOSED EXCEPT WHEN THE PT IS EXHALING. THE DIRECTIONS FOR USE FOR THIS MFR'S DEVICE INDICATE THAT THE VACUUM SYSTEM SHOULD BE SET AT 120MMHG TO 140MMHG WHEN EMPTYING THE CIRCUIT DRAIN. HOSP PERSONNEL REPORTED THAT THE VACUUM SETTING WAS AT "FULL VACUUM" WHICH CAN BE SEVERAL TIMES HIGHER THAN THE RECOMMENDED AMOUNT. IT IS CONCEIVABLE THAT A NEGATIVE PRESSURE COULD BE CREATED WHEN THE SUCTION PROBE IS INSERTED INTO THE SUCTION PORT OF THE SAFETY DRAIN. THE EXHALATION VALVE CAN CLOSE IF SUCTION CONTINUES AFTER THE SAFETY DRAIN BETWEEN TWO CLOSED VALVES, A VACUUM LOCK CAN BE CREATED AND THE PT MAY NOT BE ABLE TO EXHALE. A CHEST X-RAY REVEALED A PNEUMOTHORAX THAT REQUIRED THE INSERTION OF A CHEST TUBE. TWO DAYS LATER THE PT DIED. THE CAUSE OF DEATH WAS END STAGE RENAL DISEASE. HOSP PERSONNEL STATED THAT THE PNEUMOTHORAX DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. THE FACILITY DOES NOT FEEL THAT THE DEVICE FAILED.