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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 Problems Failure to Infuse (2340); Unexpected Shutdown (4019)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/10/2020
Event Type  Injury  
Manufacturer Narrative
Pending completion of device analysis. (b)(4).
 
Event Description
Sales representative contacted technical solutions to report a prometra ii 20 ml pump with error codes 100 and 104. Patient was originally brought in to see their managing physician due to lack of pain relief and an error code 11 on their patient therapy controller. After inquiring the pump, error codes 100 and 104 were observed. A little over a week later, the pump was explanted and replaced due to the pump displaying error codes 100, 101, 104 and 105.
 
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Brand NamePROMETRA II PROGRAMMABLE PUMP
Type of DeviceIMPLANTABLE INFUSION PUMP
Manufacturer (Section D)
FLOWONIX MEDICAL, INC.
500 international drive
suite 200
mount olive NJ 07828
Manufacturer Contact
james bennett
120 forbes blvd
suite 170
mansfield, MA 02048
9734269229
MDR Report Key10540332
MDR Text Key207131653
Report Number3010079947-2020-00294
Device Sequence Number1
Product Code LKK
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/24/2018
Device Model Number13827
Device Catalogue Number13827
Device Lot Number24304
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/16/2020 Patient Sequence Number: 1
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