2008T HEMODIALYSIS SYS., WITH CDX
Report
- Report Number
- 0002937457-2024-01233
- Event Type
- Malfunction
- Date Received
- August 26, 2024
- Date of Event
- August 20, 2024
- Report Date
- March 20, 2025
- Manufacturer
- CONCORD MANUFACTURING
- Product Code
- KDI
- UDI-DI
- 00840861100897
- PMA / PMN Number
- K150708
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION WAS PERFORMED BY A FRESENIUS FIELD SERVICE TECHNICIAN (FST). A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.
A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A 2008T HEMODIALYSIS (HD) MACHINE WAS SMOKING DURING HEAT DISINFECT MODE. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. DURING REPAIR, THE BMT FOUND THAT THE CDX BOARD WAS CHARRED AND BURNT. THE CDX WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BMT REPORTED THAT THERE WAS NO MELTING, SPARK, FLAME, OR ARCING OBSERVED. THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST. THE POWER SUPPLY, MOTHER BOARD AND POWER CORD WERE DAMAGED BY THE CDX ISSUE. THE MACHINE HAS APPROXIMATELY 39,685 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPLACED THE CDX, POWER SUPPLY, MOTHER BOARD AND POWER CORD TO RESOLVE THE ISSUE. THE BMT REPORTED THAT THE MACHINE HAS BEEN RETURNED TO SERVICE WITHOUT ISSUE. THE SAMPLES HAVE BEEN DISCARDED.
A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A 2008T HEMODIALYSIS (HD) MACHINE WAS SMOKING DURING HEAT DISINFECT MODE. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. DURING REPAIR, THE BMT FOUND THAT THE CDX BOARD WAS CHARRED AND BURNT. THE CDX WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BMT REPORTED THAT THERE WAS NO MELTING, SPARK, FLAME, OR ARCING OBSERVED. THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST. THE POWER SUPPLY, MOTHER BOARD AND POWER CORD WERE DAMAGED BY THE CDX ISSUE. THE MACHINE HAS APPROXIMATELY 39,685 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPLACED THE CDX, POWER SUPPLY, MOTHER BOARD AND POWER CORD TO RESOLVE THE ISSUE. THE BMT REPORTED THAT THE MACHINE HAS BEEN RETURNED TO SERVICE WITHOUT ISSUE. THE SAMPLES HAVE BEEN DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231210 | 2008T HEMODIALYSIS SYS., WITH CDX | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | CONCORD MANUFACTURING | 00840861100897 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |