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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 Insufficient Flow or Under Infusion (2182)
Patient Problems Fall (1848); Inadequate Pain Relief (2388); Weight Changes (2607)
Event Date 11/29/2018
Event Type  Injury  
Manufacturer Narrative
Internal complaint number: (b)(4) initially was not reportable.Additional information was received on (b)(6) 2018 concerning pump explant.
 
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 patient experienced inadequate pain relief.It was also reported that the patient had lost weight and experienced frequent falls.The pump was explanted on (b)(6) 2018.
 
Manufacturer Narrative
Internal complaint number: (b)(4).Evaluation of the device determined that the pump primed and flowed within specification.
 
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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 Key8219366
MDR Text Key132142055
Report Number3010079947-2019-00001
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00810335020228
UDI-Public0100810335020228102370817180520
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 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/20/2018
Device Model Number13827
Device Catalogue Number13827
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2019
Initial Date Manufacturer Received 12/26/2018
Initial Date FDA Received01/04/2019
Supplement Dates Manufacturer Received12/26/2018
Supplement Dates FDA Received04/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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