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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 Computer Software Problem (1112); Unexpected Shutdown (4019)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2020
Event Type  Injury  
Manufacturer Narrative
Pending further investigation and follow-up information regarding explant/device return. Internal complaint number: complaint - (b)(4).
 
Event Description
Sales representative reported a prometra ii pump that had error codes 100 and 110. The sequence of events are as follows: the patient is brought in due to an error code 11 on their ptc. Sales representative inquires the pump and observes error codes 100 and 110. Sales representative programs a soft reset. Sales representative re-inquires the pump and the error codes are cleared. The patient delivers a ptc bolus and an error code 11 is observed on the ptc. Sales representative re-inquires the patient and observes error codes 100 and 110 again. Sales representative programs another soft reset. Sales representative additionally later reported that the pump was inquired and displayed error codes 100 and 112. The battery was also reading as low. Sales representative reported that the patient will be explanted in the future, but they are having a non-pump related surgery in the coming weeks, so the patient is going to wait until they have recovered from that surgery to be 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
Manufacturer Contact
james bennett
120 forbes blvd
suite 170
mansfield, MA 02048
4269229
MDR Report Key10319715
MDR Text Key200635464
Report Number3010079947-2020-00257
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,Followup
Report Date 06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/19/2021
Device Model Number13827
Device Catalogue Number13827
Device Lot Number26325
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 Received12/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/19/2020
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: 07/24/2020 Patient Sequence Number: 1
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