FDA Adverse Event
Malfunction
Summary report: N
CADD MEDICATION CASSETTES AMBULATORY PUMP DISPOSALS
MDR report key: 24201163
·
Received January 28, 2026
Report
- Report Number
- 3012307300-2026-00622
- Event Type
- Malfunction
- Date Received
- January 28, 2026
- Date of Event
- November 1, 2025
- Report Date
- January 28, 2026
- Manufacturer
- ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
- Product Code
- LHI
- UDI-DI
- 10610586044014
- PMA / PMN Number
- K162219
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
D4, LOT # POSSIBLE LOT NUMBER: 6077773 AND 6101798. H3/H6: ONE DEVICE WAS RETURNED FOR ANALYSIS IN USED CONDITION. SERVICE HISTORY IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FUNCTIONAL TESTING WAS PERFORMED. THE CASSETTE WAS TO BE FILLED WITH 250ML OF WATER. DURING THE FILLING PROCESS, A LEAK WAS OBSERVED BETWEEN THE TUBING AND FEMALE LUER OF THE CASSETTE. THE COMPLAINT OF LEAKAGE WAS CONFIRMED. THE PROBABLE CAUSE IS DUE TO SOLVENT APPLICATION ERROR.
Description of Event or Problem · 0
IT WAS STATED LEAKAGE FROM THE CONNECTOR CONNECTION. PER REPORTER, THERE WAS NO PATIENT INVOLVED. EVALUATION OF THE RETURNED DEVICE IDENTIFIED THE FAILURE MODE OBSERVED OF LEAKAGE AT LUER TUBE BOND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260124 | CADD MEDICATION CASSETTES AMBULATORY PUMP DISPOSALS | SET, ADMINISTRATION, INTRAVASCULAR | LHI | ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. | UNKNOWN | 10610586044014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |