FDA Adverse Event
Malfunction
Summary report: N
SMARTEZ PUMP
MDR report key: 8448222
·
Received March 22, 2019
Report
- Report Number
- MW5085112
- Event Type
- Malfunction
- Date Received
- March 22, 2019
- Date of Event
- March 19, 2019
- Report Date
- March 20, 2019
- Manufacturer
- EPIC MEDICAL PTE LTD.
- Product Code
- MEB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
PT NOTIFIED AFTER HOURS TO REPORT CYSTALS AND /OR WHITE BUMPS IN FIVE SMARTEZ ACYCLOVIR 1000MG/100ML SMARTEZ DEVICE: LOT# 6018016, EXP 03/2020. PT STATES THE OTHER INFUSED DEVICES FROM THE SHIPMENT DID NOT HAVE WHITE CYSTALS EVEN AFTER ALLOWING TO REACH ROOM TEMPERATURE. PT WAS DISPENSED: ACYCLOVIR 1000MG/20ML (NDC: (B)(4), LOT # 6018016; EXP 03/2020).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235571 | SMARTEZ PUMP | PUMP, INFUSION, ELASTOMERIC | MEB | EPIC MEDICAL PTE LTD. | SE0200-100 | S8C34 | |
| 235572 | SMARTEZ PUMP | PUMP, INFUSION, ELASTOMERIC | MEB | EPIC MEDICAL PTE LTD. | SE0200-100 | 6018016 | |
| 235573 | SMARTEZ PUMP | PUMP, INFUSION, ELASTOMERIC | MEB | EPIC MEDICAL PTE LTD. | SE0200-100 | 6018016 | |
| 235574 | SMARTEZ PUMP | PUMP, INFUSION, ELASTOMERIC | MEB | EPIC MEDICAL PTE LTD. | SE0200-100 | ||
| 235575 | SMARTEZ PUMP | PUMP, INFUSION, ELASTOMERIC | MEB | EPIC MEDICAL PTE LTD. | SE0200-100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |