FDA Adverse Event
Summary report: N
EQUASHIELD
MDR report key: 1930444
·
Received October 26, 2010
Report
- Report Number
- 1930444
- Date Received
- October 26, 2010
- Date of Event
- October 14, 2010
- Report Date
- October 26, 2010
- Manufacturer
- EQUASHIELD MEDICAL LTD.
- Product Code
- LHI
- Report Source
- User Facility report
- Reporter Location
- OH, US
Narratives
Description of Event or Problem · 1
NURSE ENTERED THE PATIENT'S ROOM AND DISCOVERED THAT THE CISPLATIN INFUSION WAS LEAKING FROM THE EQUASHIELD DEVICE. THE DEVICE CONNECTIONS WERE NOTED TO BE SECURE; HOWEVER, THE INFUSION WAS LEAKING FROM THE DEVICE ITSELF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EQUASHIELD | CHEMOTHERAPY DRUG TRANSFER DEVICE | LHI | EQUASHIELD MEDICAL LTD. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | CHEMOTHERAPY |