FDA Adverse Event
Injury
Summary report: N
INFUSOMAT®
MDR report key: 20858988
·
Received December 5, 2024
Report
- Report Number
- 2532083-2024-00059
- Event Type
- Injury
- Date Received
- December 5, 2024
- Date of Event
- April 21, 2024
- Report Date
- December 5, 2024
- Manufacturer
- B. BRAUN AVITUM AG
- Product Code
- FRN
- UDI-DI
- 04046964660887
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INFUSOMAT SPACE LARGE VOLUME PUMP (MATERIAL # 87136051U, SERIAL # UNKNOWN, LOT UNKNOWN) WAS BEING USED TO ADMINISTER MEDICATIONS ON APRIL 21, 2024. ACCORDING TO THE COMPLAINANT, THE PUMP EXPERIENCED AIR IN LINE ALARMS THAT WERE NOT ABLE TO BE CLEARED. THE PATIENT DEVELOPED HYPOTENSION WHILE TROUBLESHOOTING THE PUMP ALARMS REQUIRING RAPID RESPONSE TEAM INTERVENTIONS, WHICH INCLUDED ADMINISTRATION OF THREE DIFFERENT VASOPRESSOR DRUGS, CALCIUM CHLORIDE AND ALBUMIN. A FEW HOURS LATER, THE AIR IN LINE ALARMS RETURNED, THE PUMP AND SET WERE CHANGED, BUT THE ALARMS RECURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2289847 | INFUSOMAT® | PUMP, INFUSION | FRN | B. BRAUN AVITUM AG | 04046964660887 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Male | Life Threatening| R |