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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA PROGRAMMABLE PUMP; IMPLANTABLE INFUSION PUMP
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FLOWONIX MEDICAL, INC. PROMETRA PROGRAMMABLE PUMP; IMPLANTABLE INFUSION PUMP Back to Search Results
Model Number 11827
Device Problems Unexpected Therapeutic Results (1631); Insufficient Flow or Under Infusion (2182)
Patient Problem No Code Available (3191)
Event Date 06/11/2018
Event Type  Injury  
Manufacturer Narrative
Internal complaint number: (b)(4).Results pending completion of device evaluation.
 
Event Description
It was reported that the volume of undelivered drug remaining in the drug reservoir was greater than the expected volume based upon the programmed infusion rate.The pump was subsequently explanted.
 
Manufacturer Narrative
Internal complaint number: (b)(4).Device evaluation determined that the pump inlet and outlet valves required a pull open current that exceeded the specification.
 
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Brand Name
PROMETRA PROGRAMMABLE PUMP
Type of Device
IMPLANTABLE INFUSION PUMP
Manufacturer (Section D)
FLOWONIX MEDICAL, INC.
500 international drive
suite 200
mount olive NJ 07828
MDR Report Key7680536
MDR Text Key113741481
Report Number3010079947-2018-00140
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P080012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/01/2016
Device Model Number11827
Device Catalogue Number11827
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2018
Initial Date Manufacturer Received 06/11/2018
Initial Date FDA Received07/12/2018
Supplement Dates Manufacturer Received06/11/2018
Supplement Dates FDA Received11/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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