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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 Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problem Death (1802)
Event Date 07/28/2019
Event Type  Death  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported report that patient expired due to causes unrelated to pump therapy.Patient death unrelated to pump therapy.
 
Event Description
Received information confirming that patient's death was unrelated to pump or therapy.The patient was elderly and he had been on hospice care.However, the official cause of death is unknown.
 
Manufacturer Narrative
Internal complaint number: (b)(4).A review of the dhr, 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.
 
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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 Key9474280
MDR Text Key170981160
Report Number3010079947-2019-00152
Device Sequence Number1
Product Code LKK
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 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number13827
Device Catalogue Number13827
Was Device Available for Evaluation? No
Date Manufacturer Received08/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Other;
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