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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 Appropriate Term/Code Not Available (3191); Unexpected Shutdown (4019)
Patient Problems Patient Problem/Medical Problem (2688); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/10/2019
Event Type  Injury  
Manufacturer Narrative
Internal complaint number: (b)(4).
 
Event Description
It was reported that error codes were displayed on the clinician programmer upon initial inquiry of the pump. Troubleshooting attempts were performed but were unsuccessful in clearing the error codes. The pump was subsequently 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 Key8918709
MDR Text Key155188883
Report Number3010079947-2019-00127
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/21/2017
Device Model Number13827
Device Catalogue Number13827
Device Lot Number22952
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2017
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: 08/21/2019 Patient Sequence Number: 1
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