MAUDE MDR 5591300

MDR report key
5591300
Report number
2016493-2016-00002
Event key
0
Event type
3
Date of event
2016-03-24
Date received
2016-04-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
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)CAREFUSIONBRYPAS ESY N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-04-2001. L; 2. R

Event Narratives#

N

Patient 1

CUSTOMER ADVOCACY REVIEWED THE LOG FILES FOR THE DEVICE AND FOUND THE DRAWER TIMED OUT AND FAILED CLOSE WHEN THE MEDICATION WAS SELECTED BY THE PROVIDER AND DRAWER PHYSICALLY WOULD NOT OPEN. THE DRAWER WAS RECOVERED AND REFILLED AFTER THE CASE BY PHARMACY. NO OTHER ERRORS WERE NOTED IN THE LOG FILES. FIELD SERVICE INSPECTED THE DRAWER AND FOUND NO DEFECTS WITH THE DRAWER. THEREFORE, IT IS DETERMINED THE MOST LIKELY CAUSE IS ONE OF THE PREFILLED SYRINGES HOUSED IN THE DRAWER CAUSED A MEDICATION JAM PREVENTING THE DRAWER FROM OPENING.

D

Patient 1

ANESTHESIOLOGIST REPORTS MINIDRAWER ON PYXIS ANESTHESIA SYSTEM WOULD NOT OPEN WHEN ATTEMPTING TO OBTAIN A SECOND DOSE OF SUCCINYLCHOLINE TO INTUBATE A DIFFICULT AIRWAY. THE PROVIDER REPORTED AN ALTERNATIVE MEDICATION OF PROPOFOL WAS ADMINISTERED AND THE PATIENT'S AIRWAY REMAINED UNABLE TO BE INTUBATED. THE PATIENT REQUIRED AMBU BAGGING FOR VENTILATION WHILE A SECOND DOES OF SUCCINYLCHOLINE WAS RETRIEVED BY ANOTHER PROVIDER IN AN ALTERNATE LOCATION. THE PROVIDER REPORTED NO PERMANENT HARM TO THE PATIENT AND NO CHANGE IN VITAL SIGNS. BD BECAME AWARE OF THE SERIOUS INJURY ON 04/06/2016.