FDA Adverse Event
Malfunction
Summary report: N
2008K2 HEMODIALYSIS MACHINE
MDR report key: 4102178
·
Received September 17, 2014
Report
- Report Number
- 2937457-2014-02727
- Event Type
- Malfunction
- Date Received
- September 17, 2014
- Date of Event
- August 22, 2014
- Report Date
- August 22, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA, CONCORD MANUFACTURING
- Product Code
- KDI
- PMA / PMN Number
- K994267
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION FINDINGS TO DATE INDICATED THE REPORTED MALFUNCTION OCCURRED DURING RECIRCULATION AND PRIME (MACHINE SET-UP), AND NOT DURING DIALYSIS MODE. THE USER VISUALLY OBSERVED THE SALINE BAG REFILLING WITH DIALYSATE DURING CIRCULATION. THERE HAVE BEEN NO ADVERSE EVENTS ASSOCIATED WITH THE REPORTED ISSUE. THE REPORT IS BEING INVESTIGATED BY THE MANUFACTURER VIA A CAPA. THE INVESTIGATION IS PENDING A SUPPLEMENTAL MDR WILL BE FILED AT THE COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
A USER FACILITY REPORTED A SALINE BAG BACK FILLED DURING RECIRCULATION MODE. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT. THE SENSOR BOARD WAS REPLACED BY THE TECHNICIAN. MACHINE IS BACK IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 576668 | 2008K2 HEMODIALYSIS MACHINE | KDI | FRESENIUS MEDICAL CARE NORTH AMERICA, CONCORD MANUFACTURING |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN SALINE (DISCARDED-NOT USED) |