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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 Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 06/04/2018
Event Type  Injury  
Manufacturer Narrative
Internal complaint number: (b)(4).Investigation results pending completion of device evaluation.
 
Event Description
It was reported that the volume of undelivered drug remaining in the drug reservoir was greater than the expected volume based upon the programmed infusion rate.The pump was subsequently explanted.
 
Manufacturer Narrative
Internal complaint number: (b)(4).The device evaluation determined that the root cause of the confirmed failure is due to improper storage of the pump.
 
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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 07828
MDR Report Key7660444
MDR Text Key113082441
Report Number3010079947-2018-00127
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00810335020228
UDI-Public0100810335020228102369517180520
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
Report Date 06/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date05/20/2018
Device Model Number13827
Device Catalogue Number13827
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2018
Was the Report Sent to FDA? No
Date Manufacturer Received06/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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