MAUDE MDR 8182360

MDR report key
8182360
Report number
1924066-2018-00005
Event key
0
Event type
3
Date of event
2018-10-07
Date received
2018-12-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. JON STILLMAN
Address
1720 SUBLETTE AVE. ST. LOUIS MO 63110 US
Phone
314-314-3142
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GOMCODRAINAGE PUMPALLIED HEALTHCARE PRODUCTS, INC.BTA01-72-600001-72-6000R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-1901. R

Event Narratives#

N

Patient 1

UNIT HAS NOT BEEN RETURNED FOR EVALUATION. LABEL ON UNIT AND MANUAL STATE "AFTER THE UNIT HAS BEEN OPERATING FOR FOUR OR FIVE MINUTES, IT WILL HAVE EXHAUSTED THE AIR FROM THE COLLECTION BOTTLE AND THE CYLINDER DRAINAGE WILL THEN START". WE DO NOT KNOW IF THE UNIT WAS GIVEN ENOUGH TIME WHEN STARTED. THEY TALK ABOUT USING A RED LID ON THE DISPOSABLE COLLECTION UNIT. THE UNIT SHIPPED WITH A REUSABLE BOTTLE WITH A METAL LID. WE DO NOT KNOW HOW THIS COLLECTION UNIT WORKS WITH OUR PUMP. TUBING HAD BEEN CUT AND WAS NOT PROPERLY CONNECTED. IT APPEARED TO BE SPLICED TOGETHER. ANY LEAKS IN THE TUBING WILL EFFECT THE SUCTION LEVEL. IT APPEARS THE UNIT WAS NOT SET UP PER SPECIFICATIONS. AND WAS NOT GIVEN TIME TO GET THE AIR OUT OF THE SYSTEM BEFORE USING.

D

Patient 1

IT WAS REPORTED THAT A PATIENT NEEDED BI-LATERAL CHEST TUBE AS WELL AS AN OG TUBE IN THE RESUSCITATION AREA. BOTH SUCTION MODULES WERE BEING USED FOR THE CHEST TUBES. I WENT TO GRAB THE PORTABLE SUCTION UNIT AND CONNECT IT TO THE OG TUBE. WHEN I TURNED ON THE MACHINE, THE SUCTION LIGHT TURNED ON, BUT, IT WAS NOT SUCTIONING. I ATTEMPTED TO TROUBLE SHOOT THE LACK OF SUCTION, BUT, WAS UNABLE TO SOLVE THE ISSUE. I LEFT THE SUCTION CONNECTED, SINCE THE UNIT WAS BELOW THE PATIENT, IT WAS AT LEAST ABLE TO WORK DUE TO GRAVITY. I WENT TO ANOTHER AREA TO GET THE NEW PORTABLE SUCTION UNIT. I RETURNED TO RESUSCITATION AND CONNECTED THE OG TUBE AND PRECEDED TO SUCCESSFULLY SUCTION THE PATIENT.