2008T HD SYS. W/O CDX W/BIBAG BLUE STAR
Report
- Report Number
- 0002937457-2024-00348
- Event Type
- Malfunction
- Date Received
- February 29, 2024
- Date of Event
- February 20, 2024
- Report Date
- April 22, 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
ADDITIONAL INFORMATION: B5, D9, H3 PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN EXTERIOR 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 FROM VARISTOR (RV1) WAS ENCOUNTERED. THE EVENT CAUSED THE CIRCUIT BREAKER FROM THE OUTLET TO TRIP. THE FAILURE WAS CAUSED BY THE SHORTED VARISTOR (RV1). VARISTOR (RV1) WAS REPLACED ON THE POWER CONTROL BOARD FOR RETESTING AND NO PROBLEMS WERE IDENTIFIED. 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.
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 ASSEMBLY. 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. DURING THE MACHINE INSPECTION, THE FRESENIUS FST IDENTIFIED A BURNING SMELL AND SIGNIFICANT CHARRING/BLACKENING ON THE POWER CONTROL BOARD WITHIN THE POWER SUPPLY. THEREFORE, THE COMPLAINT EVENT WAS CONFIRMED.
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 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. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND A BURNING SMELL WAS EVIDENT AND THERE WAS SIGNIFICANT CHARRING/BLACKENING ON THE POWER CONTROL BOARD WITHIN THE POWER SUPPLY. THE FST REPLACED THE POWER SUPPLY ASSEMBLY TO RESOLVE THE ISSUE. THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST AND THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS. THE MACHINE HAS APPROXIMATELY 526 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE POWER SUPPLY WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
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. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND A BURNING SMELL WAS EVIDENT AND THERE WAS SIGNIFICANT CHARRING/BLACKENING ON THE POWER CONTROL BOARD WITHIN THE POWER SUPPLY. THE FST REPLACED THE POWER SUPPLY ASSEMBLY TO RESOLVE THE ISSUE. THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST AND THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS. THE MACHINE HAS APPROXIMATELY 526 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE POWER SUPPLY WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
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. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND A BURNING SMELL WAS EVIDENT AND THERE WAS SIGNIFICANT CHARRING/BLACKENING ON THE POWER CONTROL BOARD WITHIN THE POWER SUPPLY. THE FST REPLACED THE POWER SUPPLY ASSEMBLY TO RESOLVE THE ISSUE. THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST AND THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS. THE MACHINE HAS APPROXIMATELY 526 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE POWER SUPPLY WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
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. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND A BURNING SMELL WAS EVIDENT AND THERE WAS SIGNIFICANT CHARRING/BLACKENING ON THE POWER CONTROL BOARD WITHIN THE POWER SUPPLY. THE FST REPLACED THE POWER SUPPLY ASSEMBLY TO RESOLVE THE ISSUE. THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST AND THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS. THE MACHINE HAS APPROXIMATELY 526 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE POWER SUPPLY WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
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 |
|---|---|---|---|---|---|---|---|
| 898429 | 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 |