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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA II PROGRAMMABLE PUMP; IMPLANTABLE INFUSION PUMP
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FLOWONIX MEDICAL, INC. PROMETRA II PROGRAMMABLE PUMP; IMPLANTABLE INFUSION PUMP Back to Search Results
Model Number 13827
Device Problem No Flow (2991)
Patient Problem Inadequate Pain Relief (2388)
Event Date 06/10/2019
Event Type  malfunction  
Manufacturer Narrative
Internal complaint number: complaint- (b)(4).This malfunction is being reported because it is associated with an ongoing corrective action.
 
Event Description
It was reported that error codes were displayed on the latest software version of the clinician programmer upon inquiry of the pump.This software anomaly unexpectedly stopped the pump.The patient experienced increase in pain.The error codes were able to be cleared, there are no further issues with the pump.
 
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Brand Name
PROMETRA II PROGRAMMABLE PUMP
Type of Device
IMPLANTABLE INFUSION PUMP
Manufacturer (Section D)
FLOWONIX MEDICAL, INC.
500 international drive
suite 200
mount olive NJ 07828
Manufacturer Contact
karen matis
500 international drive
suite 200
mount olive, NJ 07828
9734269229
MDR Report Key8778058
MDR Text Key150626253
Report Number3010079947-2019-00092
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00810335020228
UDI-Public0100810335020228102486117190516
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P080012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/10/2019
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
Device Operator Health Professional
Device Expiration Date05/16/2019
Device Model Number13827
Device Catalogue Number13827
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/10/2109
Initial Date FDA Received07/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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