Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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; 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; IMPLANTABLE INFUSION PUMP Back to Search Results
Model Number 13827
Device Problems Leak/Splash (1354); No Flow (2991)
Patient Problem Inadequate Pain Relief (2388)
Event Date 03/20/2020
Event Type  Injury  
Manufacturer Narrative
Pending device return and follow-up information.(b)(4).
 
Event Description
Clinical specialist reported a prometra ii pump that was explanted on (b)(6) 2020.It was reported that a catheter revision procedure was scheduled due to the patient not receiving any pain relief.During the revision surgery, the pump was confirmed to have medication in reservoir and the pump was programmed to deliver a priming bolus (prime pump & catheter) when the pump was detached from catheter.No medication was reported to be seen at pump stem and no audible valve clicks were heard.The pump was explanted and replaced.
 
Manufacturer Narrative
Additional information: patient sex and mfr site.Corrected information: device evaluated by mfr.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 nonconformances, issues or capas associated with pump function.Additional physical investigation was performed on the device, but the alleged issue was not confirmed.Functional analysis of the pump confirmed the pump successfully primed and flowed within specification.The unit flowed at 93% efficiency.As the device performed according to specification during the investigation, no definitive root cause could be determined.Internal complaint number: (b)(4).
 
Event Description
Clinical specialist reported a prometra ii pump that was explanted on (b)(6) 2020.It was reported that a catheter revision procedure was scheduled due to the patient not receiving any pain relief.During the revision surgery, the pump was confirmed to have medication in reservoir and the pump was programmed to deliver a priming bolus (prime pump & catheter) when the pump was detached from catheter.No medication was reported to be seen at pump stem and no audible valve clicks were heard.The pump was explanted and replaced.Per follow-up, there was a volume discrepancy reported during a refill, prior to the explant.A cap study was performed which was inconclusive.There were no noted catheter issues during cap study.Patient has had no mris, but did have a fall in (b)(6) 2019.Per clinical specialist, "the patient fall in (b)(6) 2019 could of contributed to the discrepancies but nothing conclusive only speculative.".
 
Manufacturer Narrative
Additional data: b5, b6, d4 (lot #, expiration date, udi), h4, h6.Pending analysis of device and further follow-up information.Internal complaint #: complaint (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROMETRA II PROGRAMMABLE PUMP
Type of Device
IMPLANTABLE INFUSION PUMP
Manufacturer (Section D)
FLOWONIX MEDICAL, INC.
500 international drive
suite 200
mount olive, nj
MDR Report Key9967923
MDR Text Key187944096
Report Number3010079947-2020-00230
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P080012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 03/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/24/2019
Device Model Number13827
Device Catalogue Number13827
Device Lot Number25309
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2020
Date Manufacturer Received06/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-