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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 Unexpected Shutdown (4019)
Patient Problem Inadequate Pain Relief (2388)
Event Date 09/18/2020
Event Type  malfunction  
Manufacturer Narrative
Device was not returned as it remains implanted. A review of the device history record, which includes verification of all steps in the manufacturing of the pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging for subject pump was performed. The review did not identify any non-conformance's, issues or capas associated with pump function. The cause of the error code 124 cannot be determined as the device is not accessible for testing. As the pump is now functioning as expected and the patient is pleased with their pain relief, no further investigation will be performed. If any further information is received, a supplemental mdr will be submitted. Internal complaint number: (b)(4).
 
Event Description
Representative reported a patient's ptc that displayed an error code 11. When the representative inquired the prometra ii programmable pump, the pump displayed error codes 100 and 124. Following a soft reset, the pump was inquired and the error codes were no longer displayed, but then the patient's ptc displayed error code 11 the following day. Per follow-up, the pump was able to be restarted. The pump is now functioning as expected and the patient is pleased with their pain relief.
 
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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
500 international drive
suite 200
mount olive, NJ 07828
9734269229
MDR Report Key10691333
MDR Text Key211716449
Report Number3010079947-2020-00321
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
Report Date 09/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/26/2021
Device Model Number13827
Device Catalogue Number13827
Device Lot Number26569
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2020
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: 10/16/2020 Patient Sequence Number: 1
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