PINNACLE®
Report
- Report Number
- 1641965-2022-00001
- Event Type
- Malfunction
- Date Received
- April 14, 2022
- Date of Event
- March 29, 2022
- Report Date
- June 5, 2024
- Manufacturer
- B. BRAUN MEDICAL INC.
- Product Code
- NEP
- UDI-DI
- 04046964957437
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT NUMBER (B)(4). THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT NUMBER (B)(4). THE DEVICE WAS RETURNED FOR INVESTIGATION. INVESTIGATION RESULTS: THE REPORTED ISSUE WAS NOT PRESENT DURING INVESTIGATION. 9 STATION VOLUMETRIC'S TESTED IN SPEC WITHOUT ALARMS.
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT NUMBER (B)(4). A CORRECTION REPORT IS BEING FILED IN ORDER TO CHANGE REPORT SECTION B1. THE PREVIOUS REPORTS WERE INCORRECTLY FILED AS "ADVERSE EVENT" BUT SHOULD HAVE BEEN FIED AS "PRODUCT PROBLEM".
AS REPORTED BY THE USER FACILITY: CUSTOMER CALLED TO REPORT AN INTERMITTENT ISSUE WITH THE PUMP DISPENSING LIPIDS INTO ORDERS THAT DO NOT HAVE LIPIDS ORDERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2669656 | PINNACLE® | SYSTEM/DEVICE, PHARMACY CO | NEP | B. BRAUN MEDICAL INC. | 601184 | 04046964957437 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |