EASYPUMP
Report
- Report Number
- 9610825-2026-00132
- Event Type
- Malfunction
- Date Received
- March 12, 2026
- Report Date
- March 16, 2026
- Manufacturer
- B.BRAUN MELSUNGEN AG
- Product Code
- MEB
- UDI-DI
- 04046964448638
- PMA / PMN Number
- K081905
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.
AS REPORTED BY THE USER FACILITY: I HAVE A LONG TERM MAINTENANCE PATIENT (4 YEARS) WHO WAS NOTING A FASTER INFUSION SINCE THEY CHANGED THE 5FU PUMPS AND WANTED TO SEE IF OTHER PATIENTS HAVE NOTICED CHANGES. HE REPORTS WITHIN 24 HOURS THE BALL SEEMS MORE EMPTY THAN PRIOR AND HE FEELS DIAPHORETIC THESE DAYS AND SEEMS COMPLETED BY WED AT MIDNIGHT OVER HIS PAST 2 INFUSIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638104 | EASYPUMP | PUMP, INFUSION, ELASTOMERIC | MEB | B.BRAUN MELSUNGEN AG | UNKNOWN | 04046964448638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Male |