FDA Adverse Event
Malfunction
Summary report: N
CADD CASSETTE RESERVOIRS - FLOW STOP NRFIT
MDR report key: 23997840
·
Received January 7, 2026
Report
- Report Number
- 3012307300-2026-00216
- Event Type
- Malfunction
- Date Received
- January 7, 2026
- Date of Event
- December 16, 2025
- Report Date
- March 19, 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
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.
Additional Manufacturer Narrative · 0
THIS EMDR WAS SUBMITTED IN ERROR AS A DUPLICATE INITIAL REPORT. THE EVENT IS BEING CAPTURED UNDER MRN 3012307300-2026-00217-00. NO FURTHER REPORTING WILL BE SUBMITTED UNDER THIS EMDR.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE LIQUID LEAKAGE OCCURRED AT THE TIP DURING MEDICINE LIQUID FILLING. AS THIS DUPLICATED THE PREVIOUS DEFECT, THE SAME LOT IS TO BE RECALLED. THE EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57262 | CADD CASSETTE RESERVOIRS - FLOW STOP NRFIT | SET, ADMINISTRATION, INTRAVASCULAR | LHI | ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V | 7609 | 6101798 | 10610586044014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |