FDA Adverse Event
Injury
Summary report: N
MINICAP TRANSFER SET
MDR report key: 3012816
·
Received March 20, 2013
Report
- Report Number
- 1416980-2013-06689
- Event Type
- Injury
- Date Received
- March 20, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 23, 2013
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- KDJ
- PMA / PMN Number
- K882498
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR H12G19068 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS SWITCHED FROM PERITONEAL DIALYSIS (PD) THERAPY TO HEMODIALYSIS (HD), DUE TO PSEUDOMONAS IN THE PD CATHETER. ON AN UNREPORTED DATE, THE PD CATHETER WAS REMOVED. NO FURTHER INFORMATION WAS GIVEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115361 | MINICAP TRANSFER SET | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |