FDA Adverse Event
Malfunction
Summary report: N
CWP
MDR report key: 5332485
·
Received December 29, 2015
Report
- Report Number
- 3019131-2015-00006
- Event Type
- Malfunction
- Date Received
- December 29, 2015
- Date of Event
- May 16, 2015
- Report Date
- December 18, 2015
- Manufacturer
- MAR COR PURIFICATION
- Product Code
- FIP
- PMA / PMN Number
- K974899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NEW INFORMATION PROVIDED BY CLINIC ON 11/19/2015, USER REPORT MW5058085. A CLINIC EMPLOYEE PULLED THE FIRE ALARM WHEN SMOKE WAS NOTICED IN THE WATER ROOM, NOT THE PATIENT AREA. RO UNIT WAS REPAIRED AND PATIENTS RESUMED TREATMENT AFTER AN APPROXIMATE 15 MINUTE DELAY. TO DATE, THERE HAVE BEEN NO REPORTS OF ILLNESS OR INJURY. THIS COMPLAINT WILL CONTINUE TO BE MONITORED IN THE MAR COR COMPLAINT HANDLING SYSTEM. SOLENOID VALVE DISPOSED OF BY USER.
Description of Event or Problem · 1
ON (B)(6) 2015 DIALYSIS CLINIC INFORMED MAR COR THAT THEIR INLET SOLENOID COIL STOPPED FUNCTIONING ON (B)(6) 2015. A 15 MINUTE DELAY OF PATIENT TREATMENT FOR 10 PATIENTS WAS REPORTED WHILE REPAIRS WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 856472 | CWP | REVERSE OSMOSIS SYSTEM | FIP | MAR COR PURIFICATION | 101366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |