FDA.reportPublic FDA data

MAUDE MDR 7247003

MDR report key
7247003
Report number
1419937-2018-00033
Event key
0
Event type
3
Date of event
2017-07-27
Date received
2018-02-07
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#

Contact
ROBERT SOKOLOWSKI
Address
1101 CORPORATE DRIVE MCHENRY IL 60050 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THOPAZ+ PUMP SALEPUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)MEDELA AGBTA079100079100R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-02-0701. O

Event Narratives#

N

Patient 1

THE?DEVICE?WAS?RETURNED?TO?MEDELA?(B)(4) FOR?EVALUATION,?WHICH?WAS?CONDUCTED?BY?A?CERTIFIED?TECHNICIAN?ON?(B)(6) 2017.??ALL?OF?THE?DATA?FROM?THE?DEVICE?WAS?DOWNLOADED?AND?ANALYZED?AND?IT?INDICATED?THAT?THE?DEVICE?WAS?WORKING?AS?INTENDED.??IT?WAS?ALSO?DETERMINED?THAT?THERE?APPEARED?TO?HAVE?BEEN?NO?HARM?TO?THE?DEVICE?AS?A?RESULT?OF?THE?IMPACT?FROM?THE?PATIENT?DROPPING?IT?ON?THE?FLOOR.??DURING?TESTING,?THE?DEVICE?CORRECTLY?SHOWED?A?FLOW?OF?0?ML/MIN,?WHICH?INDICATED?THAT?THE?DEVICE?WAS?WORKING?AS?INTENDED. IT?WAS?DETERMINED?THAT?THE?TRU-CLOSE?SYSTEM?SHOULD?NOT?BE?USED?WITH?THE?THOPAZ+?DEVICE.??THE?TRU-CLOSE?SYSTEM?WAS?CLOGGED?WITH?COAGULATED?BLOOD?AND,?THEREFORE,?THE?THOPAZ+?DEVICE?ONLY?SHOWED?THE?FLOW?FROM?THE?CLOGGED?CHEST?TUBE?TO?THE?DEVICE. IN?THE?INSTRUCTIONS?FOR?USE,?PAGE?7,?IT?IS?WRITTEN?THAT?"MEDELA?CAN?ONLY?GUARANTEE?THE?SAFE?FUNCTIONING?OF?THE?SYSTEM?WHEN?THE?THOPAZ+?IS?USED?IN?COMBINATION?WITH?THE?ORIGINAL?THOPAZ+?ACCESSORIES?(CANISTERS,?TUBINGS,?CARRYING?STRAP,?MAINS?ADAPTER,?AND?DOCKING?STATION)."??TO?WORK?OPTIMALLY?AS?INTENDED,?THE?THOPAZ+?SYSTEM?MUST?BE?CONNECTED?DIRECTLY?TO?THE?PLEURAL?SPACE?THROUGH?A?NORMAL?CHEST?TUBE.??THE?DEVICE?DOES?NOT?WORK?OPTIMALLY?AND?AS?INTENDED?WITH?ANOTHER?CHEST?TUBE?SYSTEM,?ESPECIALLY?IF?THAT?SYSTEM?IS?CLOGGED.??THE?CLINICAL?STAFF,?DOCTORS?AND?NURSES?AT?THE?(B)(6) HOSPITAL?WERE?TRAINED?THAT?THE?TWO?SYSTEMS?SHOULD?ONLY?BE?USED?SEPARATELY.

D

Patient 1

ON (B)(6) 2017:?THE?PATIENT?WAS?DIAGNOSED?AT?(B)(6) HOSPITAL?WITH?A?PNEUMOTHORAX,?AND?A?CHEST?TUBE?CALLED?TRU-CLOSE?WAS?PLACED.? ON (B)(6) 2017:?THE?TRU-CLOSE?SYSTEM?WAS?CONNECTED?TO?A?THOPAZ+?DEVICE?BECAUSE?THE?LUNG?WAS?NOT?EXPANDING.??THE?NEGATIVE?PRESSURE?WAS?SET?AT?-10?CM?H2O.??INITIALLY,?AN?AIR?LEAK?OF?700?ML/MIN?WAS?DETECTED,?BUT?SHORTLY?AFTER,?THE?AIR?LEAK?WAS?AT?0?ML/MIN.?SUBSEQUENTLY,??SHORTLY?AFTER?THE?CHEST?TUBE?INSERTION,?THE?PATIENT?INFORMED?HOSPITAL?STAFF?THAT?HE?DROPPED?THE?THOPAZ+?DEVICE?ON?THE?FLOOR.?THE?PUMP?APPEARED?TO?WORK?AFTERWARDS.??AT?THAT?TIME,?THE?STAFF?DID?NOT?CHECK?THE?CATHETER?TO?DETERMINE?IF?THE?PATIENT?CATHETER?WAS?OPEN?OR?CLOGGED. ON (B)(6) 2017:??AFTER?ONE?DAY,?A?NEW?X-RAY?OF?THE?THORAX/LUNG?WAS?TAKEN,?WHICH?SHOWED?AN?INCREASING?PNEUMOTHORAX.?THE?PATIENT?WAS?NOT?WORSENING?CLINICALLY?NOR?FROM?A?RESPIRATORY?STANDPOINT.?IN?THE?PATIENT'S?MEDICAL?RECORD,?IT?WAS?DESCRIBED?THAT?THERE?WAS?VISIBLE?COAGULATED?BLOOD?IN?THE?TUBE.??AS?A?RESULT,?THE?STAFF?FLUSHED?THE?TRU-CLOSE?TUBE?WITH?SALINE?TO?REMOVE?THE?COAGULATED?BLOOD?FROM?THE?TRU-CLOSE?SYSTEM?AND?THEY?CHANGED?THE?THOPAZ+?DEVICE?TO?A?TRADITIONAL?WATER?SEAL?DRAINAGE?SYSTEM.??AN?X-RAY?OF?THE?LUNG?AFTER?2?HOURS?WITH?THE?TRADITIONAL?SYSTEM?SHOWED?IMPROVEMENT?OF?THE?PNEUMOTHORAX,?AS?THE?SYSTEM?WAS?NO?LONGER?CLOGGED. ON (B)(6) 2017:??THE?PATIENT?WAS?TRANSFERRED?TO?(B)(6) ?HOSPITAL?TO?THE?CARDIO-THORACIC?DEPARTMENT?BECAUSE?OF?INCREASING?PNEUMOTHORAX. ON (B)(6) 2017:??THE?PATIENT?WAS?TRANSFERRED?BACK?AT?(B)(6) HOSPITAL?WITHOUT?ANY?CHEST?TUBE?OR?DRAINAGE?SYSTEM?AND?WAS?SENT?HOME?SHORTLY?THEREAFTER.