FDA Adverse Event
Malfunction
Summary report: N
DOSI-FUSER
MDR report key: 23757303
·
Received December 8, 2025
Report
- Report Number
- MW5180163
- Event Type
- Malfunction
- Date Received
- December 8, 2025
- Date of Event
- December 1, 2025
- Report Date
- December 3, 2025
- Manufacturer
- EPIC INTERNATIONAL (THAILAND) CO., LTD.
- Product Code
- MEB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PHARMACY TECHNICIAN BEGAN PREPARING A DOSI-FUSER 2 DAY 250 ML 5.2 ML/HR PUMP (REF (B)(4); LOT D250669; EXP 07-23-2027) FOR A PATIENT REQUIRING A TAKE HOME FLUOROURACIL DOSE. WHILE INJECTING THE NORMAL SALINE (NO CHEMO HAD BEEN ADDED YET), SHE HEARD AND FELT A "POP," AND NOTICED THE "BALLOON" INSIDE THE DEVICE THAT HOLD THE MEDICATION HAD POPPED. TECHNICIAN REPORTED THE EVENT TO THE PHARMACIST, WHO CONTACTED THE SALES REPRESENTATIVE FOR THE PRODUCT. LOCAL SALES REPRESENTATIVE HAPPENED TO BE IN THE AREA AND CAME TO THE HOSPITAL TO COLLECT THE FAILED PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1990384 | DOSI-FUSER | PUMP, INFUSION, ELASTOMERIC | MEB | EPIC INTERNATIONAL (THAILAND) CO., LTD. | D250669 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |