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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 16827
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/30/2022
Event Type  malfunction  
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 remains implanted and was not returned. Clinical specialist reported that the physician does not know the cause of the pump flipping. Per the instructions for use of the device, pump flipping is a known possible risk of use of the device. Internal complaint number: (b)(4).
 
Event Description
Cs stated that every time the patient presses the rx button and holds it over the pump, the patient therapy controller (ptc) reads unable to find the pump. Cs reported that the patient was initially not able to deliver boluses. Cs later followed up and confirmed that the patient's pump was flipped and their physician's assistant flipped it back and was able to deliver a bolus successfully. Cs reported that the patient's pump was sutured down at implant and that the physician did not know the reason for the pump 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 (Section G)
FLOWONIX MEDICAL, INC.
120 forbes blvd
suite 170
mansfield MA 02048
Manufacturer Contact
james bennett
500 international drive
suite 200
mount olive, NJ 07828
9734269229
MDR Report Key14750769
MDR Text Key296965147
Report Number3010079947-2022-00120
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,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16827
Device Catalogue Number16827
Device Lot Number28234
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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