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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 Excess Flow or Over-Infusion (1311)
Patient Problems Abdominal Pain (1685); Unspecified Gastrointestinal Problem (4491)
Event Date 12/17/2021
Event Type  Death  
Event Description
Agent contacted technical solutions to report that a patient had passed away. Agent reported that the patient had an mri on both knees last year, and at the time of the mri, no volume discrepancy was noted. Medications were 25milligrams/ml of morphine (6 milligrams per day), 250micrograms/ml of fentanyl (60 micrograms per day), and 7. 5micrograms/ml of prialt (2. 4 micrograms per day). A few days after the mri, the patient reportedly contacted the physician's office complaining of abdominal and gi pain. The patient was informed that if the pain continued, they should go to the er. Patient went to the er and had a ct on their abdomen at that time. Patient then came to the physician's office a few days later for a refill. During initial report to agent, an underinfusion was reported (4ml expected, 15ml returned), but this was later clarified as an overinfusion (4 ml expected volume, 0 ml returned). During this refill, a medication change was made from 7. 5 microgram/ml prialt to 10 microgram prialt/ml (concentration change not daily dose). Refill documentation has been requested and not received. Patient reportedly passed away days later. Device return and autopsy results have been requested for investigation purposes.
 
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 not returned. As the device was not returned for additional evaluation and investigation, a definitive root cause could not be determined for the alleged issue. Agent is following up with the coroner's office. Supplemental mdr will be submitted if/when additional information is received. (b)(4).
 
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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 Key13803323
MDR Text Key287385882
Report Number3010079947-2022-00044
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 02/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/27/2021
Device Model Number13827
Device Catalogue Number13827
Device Lot Number26819
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2020
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: 03/18/2022 Patient Sequence Number: 1
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