FDA.reportPublic FDA data

MAUDE MDR 6644138

MDR report key
6644138
Report number
2246980-2017-00020
Event key
0
Event type
3
Date of event
2017-05-17
Date received
2017-06-15
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. TRISH FOWLER
Address
2121 WILSHIRE STE 201 SANTA MONICA CA 90403 US
Phone
310-310-3105
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ETHOXPRESSURE INFUSER BAGETHOXKZD950089904R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-1501. O

Event Narratives#

N

Patient 1

THE CUSTOMER DID NOT RETURN THE AFFECTED DEVICE. FIFTEEN 3000 ML INFUSION BAGS WERE REMOVED FROM INVENTORY AND PRESSURIZED INTO THE RED ZONE ON THE STICK MANOMETER. NONE OF THE BAGS FAILED. THE INVESTIGATOR HAS PROCESSED SEVERAL COMPLAINTS WERE THE MESH SEAM FAILED AND THE IV BAG FELL OUT OF THE INFUSER BAG HE HAS NEVER PROCESSED A COMPLAINT WHERE THAT PRESSURE BAG ALLEGEDLY EXPLODED. TWO OF THE FULLY PRESSURIZED BAGS NEVER PROCESSED A COMPLAINT WHERE THE PRESSURE BAG ALLEGEDLY EXPLODED. TWO OF THE FULLY PRESSURIZED BAGS MENTIONED ABOVE WERE PUNCTURED WITH THE TIP OF A KNIFE TO SEE IF THESE WAS A VIOLENT REACTION WHEN PUNCTURED. BOTH BAGS QUIETLY AND NON-VIOLENTLY VENTED THE PRESSURE. THE PUNCTURES DID NOT INCREASE IN SIZE. THE AIR JUST VENTED OUT IN A VERY UNEVENTFUL MANNER. THE STICK MANOMETER ON THE PRESSURE INFUSION BAG NOT ONLY INDICATES THE PRESSURE IN THE BAG BUT IT ALSO ACTS AS A PRESSURE RELIEF VALVE SHOULD THE USER ATTEMPT TO OVER-INFLATE THE BAG USING THE HAND PUMP.

D

Patient 1

THE CUSTOMER ALLEGES "NURSE HAD IV BAG INFLATED INSIDE THE INFU-BAG. SHE WALKED PAST IT WHILE IT WAS ON THE IV POLE, IT EXPLODED APART AND SENT PRESSURE TO HER EAR." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.