FDA Adverse Event
Malfunction
Summary report: N
MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP
MDR report key: 1981004
·
Received February 8, 2011
Report
- Report Number
- 1423500-2011-01619
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 3, 2011
- Report Date
- January 12, 2011
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- KDJ
- PMA / PMN Number
- K882498
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE EVALUATION EXPECTED, BUT NOT YET COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.
Additional Manufacturer Narrative · 1
(B)(4). THIS COMPLAINT WAS CONFIRMED FOR A LOSS OF CLAMP FUNCTION ALLOWING CONTINUOUS FLOW THROUGH THE SET. THE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS NOT PERFORMED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT FOR ADVERSE TRENDS AND WILL AND TAKE CORRECTIVE AND PREVENTIVE ACTIONS, AS APPROPRIATE.
Description of Event or Problem · 1
A CUSTOMER REPORTED A TRANSFER SET THAT WOULD LEAK, EVEN WHEN CLOSED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |