2008T HD SYS. W/O CDX W/BIBAG BLUE STAR
Report
- Report Number
- 0002937457-2024-00350
- Event Type
- Malfunction
- Date Received
- February 29, 2024
- Date of Event
- February 20, 2024
- Report Date
- April 24, 2024
- Manufacturer
- CONCORD MANUFACTURING
- Product Code
- KDI
- UDI-DI
- 00840861102112
- PMA / PMN Number
- K173972
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN EXTERIOR A VISUAL INSPECTION OF THE RETURNED POWER SUPPLY FOUND THERMAL DAMAGE TO VARISTOR (RV1) AND SOOT ON THE BACK OF THE POWER CONTROL BOARD (P/N 190937). THERE IS NO OTHER DAMAGE FOUND ON THE POWER CONTROL BOARD, AND POWER SUPPLY. THE POWER SUPPLY (AS-RECEIVED CONDITION) WAS INSTALLED INTO A TEST MACHINE FOR TESTING. UPON POWER UP, A SPARK, SMOKE AND FIRE FROM VARISTOR (RV1) WERE ENCOUNTERED. THE EVENT CAUSED THE CIRCUIT BREAKER FROM THE OUTLET TO TRIP AND MORE SOOT ON THE BOARD. THE FAILURE WAS CAUSED BY THE SHORTED VARISTOR (RV1). UPON FURTHER INSPECTION IT WAS FOUND THAT THE THERMAL EVENT CAUSED BOARD DAMAGE AROUND RV1 AREA. THE POWER CONTROL WAS NOT REPAIRABLE THEREFORE NO FURTHER TESTING COULD BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND VERIFIED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. UPON COMPLETION OF THE EVALUATION, THE REPORTED ISSUE WAS CONFIRMED.
ADDITIONAL INFORMATION: D9, H6 PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, AN ON-SITE EVALUATION WAS PERFORMED BY A FRESENIUS FIELD SERVICE TECHNICIAN (FST). TO RESOLVE THE REPORTED ISSUE, THE FST REPLACED THE POWER SUPPLY. 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 ABLE TO CONFIRM THE REPORTED FAILURE MODE. THE COMPLAINT EVENT WAS CONFIRMED.
SUPPLEMENTAL MDR CREATED IN ERROR. NO CHANGES HAVE BEEN MADE AT THIS TIME.
PLANT INVESTIGATION: THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS THAT A 2008T HEMODIALYSIS MACHINE HAD THERMAL DECOMPOSITION OF THE POWER CONTROL BOARD. SMOKE WAS OBSERVED. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND REPLACED THE POWER SUPPLY TO RESOLVE THE ISSUE. MACHINE FUNCTIONAL TESTS WERE COMPLETED AND PASSED ONSITE AFTER REPAIR. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE PART WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.
A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS THAT A 2008T HEMODIALYSIS MACHINE HAD THERMAL DECOMPOSITION OF THE POWER CONTROL BOARD. SMOKE WAS OBSERVED. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND REPLACED THE POWER SUPPLY TO RESOLVE THE ISSUE. MACHINE FUNCTIONAL TESTS WERE COMPLETED AND PASSED ONSITE AFTER REPAIR. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. NO PART IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.
A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS THAT A 2008T HEMODIALYSIS MACHINE HAD THERMAL DECOMPOSITION OF THE POWER CONTROL BOARD. SMOKE WAS OBSERVED. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND REPLACED THE POWER SUPPLY TO RESOLVE THE ISSUE. MACHINE FUNCTIONAL TESTS WERE COMPLETED AND PASSED ONSITE AFTER REPAIR. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. NO PART IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.
A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS THAT A 2008T HEMODIALYSIS MACHINE HAD THERMAL DECOMPOSITION OF THE POWER CONTROL BOARD. SMOKE WAS OBSERVED. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND REPLACED THE POWER SUPPLY TO RESOLVE THE ISSUE. MACHINE FUNCTIONAL TESTS WERE COMPLETED AND PASSED ONSITE AFTER REPAIR. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. NO PART IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.
A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS THAT A 2008T HEMODIALYSIS MACHINE HAD THERMAL DECOMPOSITION OF THE POWER CONTROL BOARD. SMOKE WAS OBSERVED. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND REPLACED THE POWER SUPPLY TO RESOLVE THE ISSUE. MACHINE FUNCTIONAL TESTS WERE COMPLETED AND PASSED ONSITE AFTER REPAIR. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE PART WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.
A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS THAT A 2008T HEMODIALYSIS MACHINE HAD THERMAL DECOMPOSITION ON THE POWER CONTROL BOARD. SMOKE WAS OBSERVED COMING FROM THE POWER SUPPLY ON POWER-UP. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT. NO PART IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 898452 | 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | CONCORD MANUFACTURING | 00840861102112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |