• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA II PROGRAMMABLE PUMP (40 ML) IMPLANTABLE INFUSION PUMP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FLOWONIX MEDICAL, INC. PROMETRA II PROGRAMMABLE PUMP (40 ML) IMPLANTABLE INFUSION PUMP Back to Search Results
Model Number 16827
Device Problems Short Fill (1575); Insufficient Flow or Under Infusion (2182); Failure to Deliver (2338)
Patient Problems Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2020
Event Type  Injury  
Manufacturer Narrative
Pending device return for evaluation. Follow-up is being conducted to gather further information regarding the alleged event. (b)(4).
 
Event Description
Sales representative reported a prometra ii 40 ml pump was explanted due to a volume discrepancy and allegedly not delivering medication. The sequence of events is as follows: (b)(6) 2020: pump is implanted. Nothing remarkable is reported about the implant procedure. (b)(6) 2020: catheter dye study is conducted for an unknown reason, in which the catheter was found to be patent. A volume check was conducted in which the following volume discrepancy was observed: expected volume: 16 mls; returned volume: 19 mls. (b)(6) 2020: the physician removed the medication from the reservoir and found that the returned volume was 19 mls. The physician proceeded with explanting the pump. A demand bolus was performed on the backtable, in which the drug was observed to deliver from the pump. The catheter is reported to be a flowonix catheter. No pump errors were reported. Any falls, traumas, or mris are unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROMETRA II PROGRAMMABLE PUMP (40 ML)
Type of DeviceIMPLANTABLE INFUSION PUMP
Manufacturer (Section D)
FLOWONIX MEDICAL, INC.
500 international drive
suite 200
mount olive, nj
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 
4269229
MDR Report Key9950024
MDR Text Key187264468
Report Number3010079947-2020-00229
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/22/2020
Device Model Number16827
Device Catalogue Number16827
Device Lot Number25936
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2019
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: 04/10/2020 Patient Sequence Number: 1
-
-