BD ALARIS SMARTSITE GRAVITY SET
Report
- Report Number
- 9616066-2025-03695
- Event Type
- Malfunction
- Date Received
- December 8, 2025
- Date of Event
- October 20, 2025
- Report Date
- December 12, 2025
- Manufacturer
- SISTEMAS MEDICOS ALARIS S.A DE C.V.
- Product Code
- FPA
- UDI-DI
- 10885403234439
- PMA / PMN Number
- K022209
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION RESULTS: DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. NO PRODUCT WILL BE RETURNED PER CUSTOMER. NO INVESTIGATION WAS PERFORMED.
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT OCCURRED 3 TIMES. THE VALVE PROXIMAL TO THE PATIENT ON THE BD TUBING DID NOT DEPLOY. IT SIMPLY DID NOT WORK (TOTAL OCCLUSION). THIS INCIDENT HAPPENED TWICE WITH A SYRINGE PUMP TUBING (REF T-03072S). IT HAPPENED ANOTHER TIME WITH B-BRAUN TUBING (REF363904). WE NOTICED IT BEFORE ANESTHETIZING THE PATIENT (SO THERE WERE NO CONSEQUENCES FOR THE PATIENT). INCIDENTS X3 OCCURRED IN THE WEEK OF OCTOBER 20, 2025. THIS PROBLEM HAS ALREADY BEEN RAISED BY HDQ, AND THE TUBINGS ARE STILL IN CIRCULATION. COMPLAINT NOTICED: DURING / AFTER USE PROBLEM FREQUENCY: A FEW TIMES.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2422281 | BD ALARIS SMARTSITE GRAVITY SET | INTRAVASCULAR ADMINISTRATION SET | FPA | SISTEMAS MEDICOS ALARIS S.A DE C.V. | 25025431 | 10885403234439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |