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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP

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FLOWONIX MEDICAL, INC. PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP Back to Search Results
Model Number 11827
Device Problems Device Operates Differently Than Expected (2913); No Flow (2991)
Patient Problem Inadequate Pain Relief (2388)
Event Date 11/29/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional information was received on 1/30/2018 concerning pump explant.
 
Event Description
It was reported that the physician had difficulty refilling the pump. The patient was experiencing inadequate pain relief. Under fluoroscopy the catheter access port (cap) was accessed and the physician was unable to aspirate fluid from the pump. The physician decided to explant the pump.
 
Manufacturer Narrative
(b)(4). A root cause for the confirmed failure was undetermined as the device worked per specification. However, it is probable that it could be related to an obstruction in the flow path related to drug or drug precipitant, which may have resolved during investigation/destructive testing.
 
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Brand NamePROMETRA PROGRAMMABLE PUMP
Type of DeviceIMPLANTABLE INFUSION PUMP
Manufacturer (Section D)
FLOWONIX MEDICAL, INC.
500 international drive
suite 200
mount olive NJ 07828
Manufacturer Contact
karen matis
500 international drive
suite 200
mount olive, NJ 07828
9734269229
MDR Report Key7297340
MDR Text Key100973503
Report Number3010079947-2018-00022
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2016
Device Model Number11827
Device Catalogue Number11827
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2014
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: 02/26/2018 Patient Sequence Number: 1
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