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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 No Flow (2991)
Patient Problem Cramp(s) /Muscle Spasm(s) (4521)
Event Date 03/29/2021
Event Type  Injury  
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 patient reportedly wanted to keep the pump for their own independent investigation. Continued follow up is being performed by the cs to get in touch with the patient/patient's family regarding their post explant health. As the device was not returned for additional evaluation and investigation, a definitive root cause could not be determined. Internal complaint number: (b)(4).
 
Event Description
Clinical specialist (cs) contacted technical solutions to report a patient that was brought into the hospital with baclofen withdrawal symptoms. Cs reported that the patient was experiencing an increase in muscle stiffness and extreme sweating. Cs also reported that a volume check was not done on the pump because the physician did not want to remove any medication due to the location not having any baclofen readily available to refill the pump. Additionally, the patient was found to have a blood infection. Cs stated that they could not confirm whether the cause of the blood infection was known, but that the infection was not related to pump therapy. A dye study was performed in which the cap could not be aspirated. The patient's pump was later explanted.
 
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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 Key11731777
MDR Text Key247506664
Report Number3010079947-2021-00118
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/19/2020
Device Model Number16827
Device Catalogue Number16827
Device Lot Number26017
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2019
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: 04/27/2021 Patient Sequence Number: 1
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