• 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 CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR

  • 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 CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Failure to Infuse (2340); Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2022
Event Type  malfunction  
Event Description
It was reported the infusion completed but the bag was still full. The event log was analyzed and could not find anything out of the ordinary. Bench testing the pump found no issues. No patient injury was reported.
 
Manufacturer Narrative
Catalog number is unknown. Udi information is unknown. Operator of device is unknown. No information has been provided to date. Premarket (510k) number is unknown. Operator of device is patient/consumer. Initial reporter also sent report to fda is unknown. No information has been provided to date. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15322197
MDR Text Key301011493
Report Number3012307300-2022-08843
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 08/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2022
Was the Report Sent to FDA? No
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

-
-