FDA.reportPublic FDA data

MAUDE MDR 7009535

MDR report key
7009535
Report number
1314417-2017-00002
Event key
0
Event type
3
Date of event
2017-09-14
Date received
2017-11-08
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
MS. CARRIE FORTUNA
Address
2710 NORTHRIDGE DR. SUITE A GRAND RAPIDS MI 49544 US
Phone
616-616-6162
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ETHOXPRESSURE INFUSION BAGETHOX LLC.KZD4005HY N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-080

Event Narratives#

N

Patient 1

THE CUSTOMER DID NOT RETURN THE AFFECTED DEVICE AND NO LOT NUMBER WAS PROVIDED. THE CUSTOMER'S DESCRIPTION INDICATES THAT THE DEVICE COULD BE PRESSURIZED BUT IT WOULD HOLD NO PRESSURE. AFTER FILING THE COMPLAINT, THE CUSTOMER PROVIDED ADDITIONAL INFORMATION WHICH INDICATED THAT THE BAG WAS TESTED PRIOR TO USE AND PRESUMABLY FUNCTIONED AS INTENDED BECAUSE A CATHETER WAS INSERTED IN THE PATIENT BEFORE THE BAG "LOST" PRESSURE. IT ALSO STATED THAT THE STAFF IS ACCUSTOMED TO THESE DEVICES AND FOLLOWED THE IFU AND THAT THEY HAVE NOT HAD ANY ISSUES SINCE. BASED ON THE LIMITED INFORMATION PROVIDED, THE INVESTIGATOR'S CONCLUSION IS THAT THIS WAS AN INCIDENT OF THE USER NOT FOLLOWING THE IFU AND THE DEVICE HAVING A BAD CHECK VALVE. THE DEVICE COULD BE PRESSURIZED BUT THE STOPCOCK WAS NOT PLACED IN THE CORRECT POSITION TO MAINTAIN PRESSURE. THE BAD CHECK VALVE WAS NOT ABLE TO MAINTAIN PRESSURE AS WELL AS BAGS MADE WITH GOOD CHECK VALVES. THIS WOULD EXPLAIN WHY THE DEVICE PASSED THE PRE-TEST AND WAS PLACED IN SERVICE BUT THE DID NOT ADEQUATELY HOLD PRESSURE DURING THE PROCEDURE. EVEN WITH A BAD CHECK VALVE THE DEVICE WOULD HAVE MAINTAINED PRESSURE AS INTENDED IF THE STOPCOCK HAD BEEN PLACED IN THE "MAINTAIN" POSITION.

D

Patient 1

THE CUSTOMER ALLEGES THAT "BAG DID NOT MAINTAIN PRESSURE. PATIENT HAD LOSS OF BLOOD PRESSURE AND BAG WAS DEFLATED SO CATHETER WERE BLOCKED. " NO OTHER DETAILS WERE PROVIDED.

N

Patient 1

THE CUSTOMER RETURNED THE AFFECTED DEVICE AFTER THE INITIAL MDR WAS SUBMITTED ON 11-8-2017. FUNCTIONAL AND VISUAL INSPECTIONS WERE PREFORMED AND THE PRODUCT FUNCTIONED AS INTENDED.

D

Patient 1

THE CUSTOMER ALLEGES THAT " BAG DID NOT MAINTAIN PRESSURE. PATIENT HAD LOSS OF BLOOD PRESSURE AND BAG WAS DEFLATED SO CATHETER WERE BLOCKED." NO OTHER DETAILS WERE PROVIDED.