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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 Seroma (2069)
Event Date 04/21/2021
Event Type  Injury  
Manufacturer Narrative
Device was returned for additional evaluation and investigation. 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-conformances, issues or capas associated with pump function. Additional physical investigation was performed on the device, but the alleged issue could not be confirmed. Visual inspection of the pump did not show any anomalies. Functional analysis of the pump showed that the device primed and flowed within specification. During investigation captured in mfr 3010079947-2021-00140, it was determined that the catheter had a leak in it. A slice/cut lengthwise was observed at the leak sight. It is likely that this catheter leak is related to the allegation of the dye not being observed coming out of the end of the catheter, as the dye was likely leaking out of the side of the catheter through the fracture point. Internal complaint number: (b)(4).
 
Event Description
It was reported that a patient's pump was explanted and replaced. The original reason for the surgery was that a seroma was present in the pump pocket. The cause of seroma was unknown. During surgery, a cap study was performed and, "we never saw the dye come out the catheter". Therefore, the catheter was replaced. Reporter stated that the physician wanted to take the pump out because the patient is young and, "they weren't sure if the pump was working. " upon explant, they were unable to push a bead through when they tried. Mfr 3010079947-2021-00140 was opened to address the catheter replacement.
 
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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 (Section G)
FLOWONIX MEDICAL, INC.
120 forbes blvd
suite 170
mansfield MA 02048
Manufacturer Contact
james bennett
500 international drive
suite 200
mount olive, NJ 07828
9734269229
MDR Report Key11855104
MDR Text Key252409166
Report Number3010079947-2021-00141
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 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2017
Device Model Number13827
Device Catalogue Number13827
Device Lot Number22921
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2017
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: 05/20/2021 Patient Sequence Number: 1
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