FDA.reportPublic FDA data

MAUDE MDR 5698313

MDR report key
5698313
Report number
2016493-2016-00003
Event key
0
Event type
3
Date of event
2016-04-03
Date received
2016-06-03
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
MS. ALLISON SUAREZ
Address
10020 PACIFIC MESA BLVD. SAN DIEGO, CA 92121 US
Phone
858-858-8586
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PYXIS ANESTHESIA SYSTEM (PAS)AUTOMATED DISPENSING CABINET (ADC'S)CAREFUSIONBRYPAS4000Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-06-030

Event Narratives#

N

Patient 1

CAREFUSION RECEIVED A MEDWATCH (SUS MW5061518) ON MAY 9, 2016 FROM (B)(6) OF (B)(6). THE REPORT DATE ON THE MEDWATCH LISTS (B)(6) 2016. ON (B)(6) 2016 (B)(6) FROM (B)(6) HOSPITAL IN (B)(6) OPENED A CASE WITH CAREFUSION DOCUMENTING THE SAME INCIDENT. A CAREFUSION FIELD SERVICE TECHNICIAN WENT ON SITE ATTEMPTED TO REPLICATE THE ISSUE WITHOUT SUCCESS. THE MINI DRAWER FUNCTIONED CORRECTLY. NEITHER REPORT ALLEGES PATIENT HARM.

D

Patient 1

CUSTOMER REPORTS THAT A MINI DRAWER ON A PYXIS ANESTHESIA SYSTEM 4000 DID NOT FUNCTION PROPERLY CAUSING MEDICATIONS IN OTHER DRAWERS TO BE UNAVAILABLE. THE CUSTOMER WAS ABLE TO RETRIEVE MEDIATIONS FROM A NEARBY DEVICE. NO PATIENT HARM REPORTED AS A RESULT OF THIS INCIDENT.