CARDIOMEMS¿ HOSPITAL SYSTEM
Report
- Report Number
- 3004936110-2025-00763
- Event Type
- Malfunction
- Date Received
- April 29, 2025
- Report Date
- August 25, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- MOM
- UDI-DI
- 05415067034724
- PMA / PMN Number
- P100045
- Removal / Correction Number
- FA-Q325-HF-1
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE INVESTIGATION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.
THIS REPORT IS BEING SENT TO CORRECT THE MISSING INFORMATION IN SECTION G3 FROM MDR-2025-18000-02 - DATE RECEIVED BY MANUFACTURER.
FA-Q325-HF-1 CARDIOMEMS DUPLICATE PATIENT PROFILE ADVISORY NOTICE ISSUED BY ABBOTT ON 20 AUG 2025.
CAPA 139725 HAS BEEN INITIATED TO INVESTIGATE THIS ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THAT NO NON-CONFORMANCES WERE IDENTIFIED THAT ARE RELATED TO THE REPORTED EVENT.
ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. MDR-2025-18003 WAS CREATED FOR THE SECOND PATIENT (PATIENT B).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1222301 | CARDIOMEMS¿ HOSPITAL SYSTEM | SYSTEM, HEMODYNAMIC, IMPLANTABLE | MOM | ABBOTT MEDICAL | CM3100 | 8955182 | 05415067034724 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |