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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 Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 10/03/2019
Event Type  Injury  
Manufacturer Narrative
Internal complaint number: (b)(4).
 
Event Description
It was reported that the catheter connector broke off during catheter revision. Physician was trying to remove the catheter lock from the pump to connect to the new catheter segment, when the catheter connector came out of the pump stem. The physician then put the connector back into the pump stem. She reports she then tested the pump to confirm if it was functional, of which it was confirmed that the pump was functional. However, it was reported that it was decided that her back-up pump would be used and implanted in this patient.
 
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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, NJ 07828
9734269229
MDR Report Key9495038
MDR Text Key197937461
Report Number3010079947-2019-00162
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/22/2018
Device Model Number13827
Device Catalogue Number13827
Device Lot Number23829
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2017
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: 12/19/2019 Patient Sequence Number: 1
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