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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 Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)
Patient Problem Discomfort (2330)
Event Date 11/17/2021
Event Type  Injury  
Manufacturer Narrative
Device was returned for additional evaluation and investigation. 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. Additional physical investigation was performed on the device, but the alleged issue could not be confirmed. Visual inspection of the pump did not find any exterior anomalies. Functional analysis of the pump confirmed the pump successfully primed and flowed within design specifications. No issue was found with this pump. The root cause of the issue is unknown. Internal complaint number: (b)(4).
 
Event Description
Clinical specialist (cs) reported that a pump was replaced with a medtronic device. Initially, cs contacted technical solutions to report an overinfusion volume discrepancy. The expected volume was 6. 9ml and the actual aspirated volume was 0ml. The patient had reported "feeling sick. " the nurse covering the patient confirmed that they had accessed the reservoir by entering 5 ml of saline and letting it passively aspirate back into the syringe. The same was done with 10ml of saline. It was later reported that the patient did not have any symptoms. The physician reported to believe that the pump valves were not open and reported to be comfortable placing medication back into the pump. Additional communication confirmed that, at the patient's next refill appointment, an underinfusion volume discrepancy was observed. It was reported that the entire 20ml was returned. As a result of this, the physician later elected to replace the pump with a medtronic device.
 
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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 Key13618780
MDR Text Key286441682
Report Number3010079947-2022-00027
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 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/23/2021
Device Model Number13827
Device Catalogue Number13827
Device Lot Number27194
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/23/2020
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: 02/28/2022 Patient Sequence Number: 1
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