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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 Use of Device Problem (1670)
Patient Problem Insufficient Information (4580)
Event Date 04/12/2022
Event Type  Injury  
Event Description
Office manager of physician's office contacted technical solutions to report a patient's adverse reactions after a refill procedure.During the call, technical solutions determined that during the refill, only 9ml of the 20ml was able to be pulled back when the volume check was performed.Based on this information, this issue is believed to a pocket fill rather than a pump malfunction.Narcan was administered to the patient and they were taken to the hospital.Office manager reported that the patient is doing fine now.
 
Manufacturer Narrative
Pending follow up information regarding patient symptoms.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.Internal complaint number: (b)(4).
 
Manufacturer Narrative
Although several attempts were made to confirm details regarding the patient's symptoms, no additional information was able to retrieved from the physician's office.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).
 
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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
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 Key14380172
MDR Text Key292600988
Report Number3010079947-2022-00082
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00810335020242
UDI-Public(01)00810335020242(10)27763(17)220412
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 Physician
Type of Report Initial,Followup
Report Date 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/12/2022
Device Model Number16827
Device Catalogue Number16827
Device Lot Number27763
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexFemale
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