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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 No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2021
Event Type  Injury  
Manufacturer Narrative
Pending completion of device analysis and review of device history record. Internal complaint number: (b)(4).
 
Event Description
During a catheter revision surgery that was being performed due to an irregular catheter dye study and under infusion volume discrepancy, it was found that the patient's catheter had been sliced. The physician is alleging that this slice is from the previous draining of the hematoma. The catheter was removed from the patient and the pump was then primed three times while still inside of the patient. Beads were reported to not have been seen. The pump was then taken to the back table and two more primes were done immediately in which beads were not visibly seen again. The patient's pump was explanted and replaced. The original catheter revision surgery was extended and delayed by the issues found with the pump and subsequent pump explant. Mfr 3010079947-2021-00134 was opened to address the patient's hematoma and mfr 3010079947-2021-00136 was opened to address the patient's catheter revision surgery.
 
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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 Key11812332
MDR Text Key252409546
Report Number3010079947-2021-00137
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,Followup
Report Date 04/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/12/2022
Device Model Number13827
Device Catalogue Number13827
Device Lot Number27510
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2021
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: 05/12/2021 Patient Sequence Number: 1
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