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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 Unintended Movement (3026)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 06/19/2019
Event Type  Injury  
Manufacturer Narrative
Internal complaint number: (b)(4).
 
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. A cap study was performed and it was observed that the catheter was not patent. The physician determined that the pump had flipped multiple times. A revision surgery was performed to revise the catheter since it had twisted as a result of the pump flipping and the pump was re-sutured to prevent further flipping.
 
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Brand NamePROMETRA II 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 Key8902537
MDR Text Key154591263
Report Number3010079947-2019-00124
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
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/20/2018
Device Model Number13827
Device Catalogue Number13827
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2018
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: 08/16/2019 Patient Sequence Number: 1
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