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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC PROMETRA PATIENT THERAPY CONTROLLER; INFUSION PUMP PROGRAMMER
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FLOWONIX MEDICAL, INC PROMETRA PATIENT THERAPY CONTROLLER; INFUSION PUMP PROGRAMMER Back to Search Results
Model Number 12860
Medical Device Problem Code Device Displays Incorrect Message (2591)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/23/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported that the patient therapy controller (ptc) was reconfigured during an appointment.After the reconfiguration was complete, the ptc was removed from the charger.The ptc then displayed a message indicating that the device must be configured before use.Troubleshooting was performed and the issue was resolved.There were no patient effects reported, and the device will not be returned.
 
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Brand Name
PROMETRA PATIENT THERAPY CONTROLLER
Common Device Name
INFUSION PUMP PROGRAMMER
Manufacturer (Section D)
FLOWONIX MEDICAL, INC
500 international drive
suite 200
mount olive NJ 07828
MDR Report Key5967585
Report Number3006803715-2016-00539
Device Sequence Number16366329
Product Code LKK
UDI-Device Identifier00810335020174
UDI-Public010081033502017411160525
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P080012
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Model Number12860
Device Catalogue Number12860
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/23/2016
Initial Report FDA Received Date09/21/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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