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: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. CADD EXTENSION SET; 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
 

ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7106-24
Medical Device Problem Codes Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182); Air/Gas in Device (4062)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/04/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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 information becomes available.
 
Event or Problem Description
It was reported that during infusion with cadd extension set experienced leakage from the tubing¿s plastic circular element.Due to the leakage, cassettes required early replacement, resulting in a reduced drug dose with a total loss of 3.24 mcg from 25.5 ml diluted in the cassette.Despite strong protection of the extension set, leaks were observed in the filter, leaving wet marks on the patient¿s clothing, along with air bubbles and steam inside the filter.The event occurred during infusion.There was patient involvement and no patient harm/adverse event reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CADD EXTENSION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
ave calidad no. 4, parque
industrial internacional
tijuana 22425
MX  22425
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key25659344
Report Number3012307300-2026-06635
Device Sequence Number21445679
Product Code FPA
UDI-Device Identifier10610586023279
UDI-Public(01)10610586023279(17)300318(10)6101989
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
K974013
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/29/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Catalogue Number21-7106-24
Device Lot Number6101989
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2026
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/08/2026
Initial Report FDA Received Date06/29/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured04/02/2025
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Patient SexMale
-
-