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: OMNICELL, INC. OMNICELL I.V.SOFT ROBOT STATION; SYSTEM/DEVICE, PHARMACY COMPOUNDING
  • 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
 

OMNICELL, INC. OMNICELL I.V.SOFT ROBOT STATION; SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/16/2021
Event Type  Injury  
Event Description
Experienced issues with coring while using omnicell i.V.Soft robots to compound.Small cores of rubber from vial stopper found on (b)(6) 2020 in rocuronium.Contacted manufacturer who advised a change from hospital rocuronium to xgen rocuronium.Change made as suggested with continued finding of rubber cores with the xgen rocuronium.In addition cores discovered with vasopressin.Decision made to pause use of device based on frequency of coring observed.Vendor (omnicell) tested use of filter needle and resumed production in (b)(6) of 2021 with use of filter needle to filter out any cores.At present only able to safely compound syringes (straight draw from vial) with filter needle.Not able to use functionality of compounding bags due to issues with coring.Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OMNICELL I.V.SOFT ROBOT STATION
Type of Device
SYSTEM/DEVICE, PHARMACY COMPOUNDING
Manufacturer (Section D)
OMNICELL, INC.
MDR Report Key11874875
MDR Text Key252709261
Report NumberMW5101521
Device Sequence Number1
Product Code NEP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 05/21/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received05/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
-
-