FDA Adverse Event
Death
Summary report: N
EQUISTREAM
MDR report key: 12827840
·
Received November 17, 2021
Report
- Report Number
- MW5105357
- Event Type
- Death
- Date Received
- November 17, 2021
- Date of Event
- November 4, 2021
- Report Date
- November 12, 2021
- Manufacturer
- BARD ACCESS SYSTEMS, INC.
- Product Code
- MSD
- Report Source
- Voluntary report
- Reporter Location
- ND, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE PATIENT'S MOTHER WAS CHANGING THE DRESSING AROUND THE DIALYSIS CATHETER AND INADVERTENTLY CUT THE TUBING BENEATH ONE OF THE PORTS. THE PATIENT BEGAN BLEEDING OUT THROUGH THE CUT CATHETER END AND COLLAPSED AND 911 WAS CALLED. THE BLEEDING COULD NOT BE STOPPED UNTIL THE TUBE WAS CLAMPED IN THE EMERGENCY ROOM. DESPITE ALL EFFORTS INCLUDING TRANSFUSION THE PATIENT COULD NOT BE RESUSCITATED. SHE DIED OF EXSANGUINATION. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1726887 | EQUISTREAM | CATHETER, HEMODIALYSIS, IMPLANTED | MSD | BARD ACCESS SYSTEMS, INC. | 5905280 | REES2407 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Female | Death |