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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 Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 10/03/2019
Event Type  Injury  
Manufacturer Narrative
Internal complaint number: (b)(4).
 
Event Description
It was reported that the catheter connector broke off during catheter revision.Physician was trying to remove the catheter lock from the pump to connect to the new catheter segment, when the catheter connector came out of the pump stem.The physician then put the connector back into the pump stem.She reports she then tested the pump to confirm if it was functional, of which it was confirmed that the pump was functional.However, it was reported that it was decided that her back-up pump would be used and implanted in this patient.
 
Manufacturer Narrative
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 non-conformances, issues or capas associated with pump function.Device was returned for additional evaluation and investigation.Additional physical investigation was performed on the device, and the alleged issue was confirmed.Visual analysis confirmed the metal tip had been pulled from the rubber cannula on the cap.The metal tip was viewed under magnification, confirming the metal tip had been pulled from the compression sleeve it had been crimp collared to.This crimp collar has been failure strength axial tested.The result of the test found that they are able to resist an axial load of 1.1lb.Statistical analysis showed there is a 95% confidence that 95% of the values are above 9.4 lbs.The cause for the metal tip coming out the cannula is the inadvertent use of excessive force pulling on the catheter access port attachment, inadvertently pulling the metal tip out of the cannula.Internal complaint number: (b)(4).
 
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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 Key9495038
MDR Text Key197937461
Report Number3010079947-2019-00162
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00810335020228
UDI-Public0100810335020228102382917180622
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 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/22/2018
Device Model Number13827
Device Catalogue Number13827
Device Lot Number23829
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2019
Initial Date Manufacturer Received 10/03/2019
Initial Date FDA Received12/19/2019
Supplement Dates Manufacturer Received10/03/2019
Supplement Dates FDA Received07/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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