FDA Adverse Event
Injury
Summary report: N
LIFESITE HEMODIALYSIS ACCESS SYSTEM
MDR report key: 448869
·
Received March 19, 2003
Report
- Report Number
- 1225459-2003-00012
- Event Type
- Injury
- Date Received
- March 19, 2003
- Report Date
- February 19, 2003
- Manufacturer
- VASCA, INC.
- Product Code
- MSD
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ON 2/19/2003, THE FACILITY'S NURSE INFORMED THE MFR (MFR.) OF THE FOLLOWING: THE PT HAD AN INFECTION (MRSA), BUT REFUSED ANTIBIOTIC THERAPY. THE HOSP STAFF EXPRESSED CONCERN BECAUSE THE PT ALSO REFUSED TO ALLOW EXPLANT WHEN ADVISED. THE DEVICES WERE EXPLANTED IN 2003, AND REPLACED WITH A QUINTON CATHETER. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESITE HEMODIALYSIS ACCESS SYSTEM | BLOOD ACCESS DEVICE | MSD | VASCA, INC. | LHAS14120 | 331 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |