Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEM; WARMER, THERMAL, INFUSION FLUID
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST PAUL LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEM; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number H1100
Device Problems Electrical /Electronic Property Problem (1198); Pressure Problem (3012)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
It was reported that the level 1 normoflo irrigation fast flow system was pulling too much water and causing the circuit breakers to trip.No patient injury or complications were reported in relation to this event.
 
Manufacturer Narrative
Investigation completed on a smiths medical fluid warming|level 1 normoflo irrigation fast flow systems - h-1100 series complaint of pulling to much water and causing circuit breaker to trip was duplicated and confirmed.Evaluated by fill device reservoir tank with water, installed test flow rate e6645 due (b)(6) 2021, power on the device, and test read above 1.0 gallon per minute.Removed back panel, unplugged pump assembly connector from the main pcb.Measure pump assembly with test fluke multimeter e2303 due (b)(6) 2020, reading show 13.5ohms which is out of specification.This was isolated to a faulty pump assembly.Action taken to replace the pump and preventative action for pcb board.Summary repairs : received device with no rolling base.Device was manufactured in 2020-03-04.Removed back panel, unplugged pump assembly connector from the main pcb.Measure pump assembly with test fluke multimeter e2303 due (b)(6) 2020, reading show 13.5ohms which is out specification.This confirmed customer reported reason.An additional issue were also found crack return tube.This return tube issue is being addressed through capa 18moak055.Replaced main pcb as preventative action.Replaced faulty pumps assembly and crack return tube.Installed tempcheck test fixture e5993 due (b)(6) 2020.Measured temperature was 41.7c degrees which is within tolerance.Device passed all functional and electrical tests.
 
Event Description
Device evaluation completed and summary in h 10.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEM
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10589210
MDR Text Key208622267
Report Number3012307300-2020-09834
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberH1100
Device Catalogue NumberH1100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2020
Was the Report Sent to FDA? No
Date Manufacturer Received12/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-