BD ALARIS PUMP MODULE SMARTSITE INFUSION SET
Report
- Report Number
- 9616066-2024-00833
- Event Type
- Malfunction
- Date Received
- June 4, 2024
- Date of Event
- April 17, 2024
- Report Date
- December 16, 2024
- Manufacturer
- SISTEMAS MEDICOS ALARIS S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 10885403227998
- PMA / PMN Number
- K221327
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
THE CUSTOMER REPORTED AIR IN LINE AND RETURNED 3 SETS OF MATERIAL 2426-0007, LOT 24019384. UPON INITIAL VISUAL EXAMINATION, THE SETS HAD NO DEFECTS OR ABNORMALITIES. THE SETS WERE INFUSED WITH WATER AND LEFT TO RUN FOR 1 HOUR. THERE WAS STILL NO ISSUE WITH THE SETS, AND THE REPORT OF AIR IN LINE COULD NOT BE VERIFIED.
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD AIR IN LINE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. RCC RECEIVED A COMPLAINT VIA COMMUNITY. PIR ATTACHED. AIR IN LINE DUE TO DEFECTIVE TUBING.
MATERIAL# 2426-0007 BATCH# 24019384 IT WAS REPORTED BY CUSTOMER THAT AIR IN LINE DUE TO DEFECTIVE TUBING VERBATIM RCC RECEIVED A COMPLAINT VIA COMMUNITY. PIR ATTACHED. AIR IN LINE DUE TO DEFECTIVE TUBING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 609778 | BD ALARIS PUMP MODULE SMARTSITE INFUSION SET | INTRAVASCULAR ADMINISTRATION SET | FPA | SISTEMAS MEDICOS ALARIS S.A. DE C.V. | 24019384 | 10885403227998 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |