2008T HD SYS. CDX W/BIBAG BLUE STAR
Report
- Report Number
- 0002937457-2023-00048
- Event Type
- Malfunction
- Date Received
- January 11, 2023
- Date of Event
- January 9, 2023
- Report Date
- January 23, 2023
- Manufacturer
- CONCORD MANUFACTURING
- Product Code
- KDI
- UDI-DI
- 00840861102099
- PMA / PMN Number
- K173972
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: AN INSPECTION ON THE RETURNED ROTOR SHOWED ONE OF THE REAR GUIDE SHEAVE (POLYMER SLEEVE) DEFORMED AND LOOSE. THE OTHER REAR GUIDE PIN HAS A MISSING SLEEVE. THERE ARE NO DISCREPANCIES WITH THE FRONT GUIDE PIN AND SLEEVES. SEE ATTACHED PHOTOS. INSTALL THE RETURNED ROTOR ONTO THE BLOOD PUMP MODULE OF A TEST MACHINE FOR TESTING. A PATIENT TEST WAS PERFORMED WITH FRESENIUS¿S COMBISET BLOODLINE AND WATER IN DIALYSIS. THE ROTOR DID NOT DAMAGE THE BLOODLINE AND THERE WERE NO FLUID LEAKS OR ALARMS DURING TESTING. THE DEFECTIVE SLEEVE DID NOT SLIP OUT AND REMAINED INTACT WITH GUIDE PIN DURING TESTING. 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. THE COMPLAINT WAS CONFIRMED.
PLANT INVESTIGATION: THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT THE BLOOD PUMP ROTOR TUBING GUIDE WAS LOOSE CAUSING DAMAGE TO THE BLOOD PUMP TUBING DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. UPON FOLLOW-UP, THE BMT STATED THE BLOOD PUMP ROTOR OF THE MACHINE, A FRESENIUS 2008T MACHINE, CUT OPEN THE BLOOD PUMP TUBING AND CAUSED A BLOOD LEAK TO OCCUR. THE BMT STATED THE ROTOR SLEEVES AROUND THE PINS WERE LOOSE AND SLIPPING OFF AND CAUSING THE BLOOD PUMP TO CUT THE TUBING. THE PREVIOUS ROTOR WAS THE ORIGINAL TO THE MACHINE. THE BMT STATED THE ROTOR LASTED 5,000 MACHINE HOURS BEFORE THE FAILURE OCCURRED. THE BMT ALSO STATED THAT FRESENIUS BLOODLINES WERE USED FOR TREATMENT AND CONFIRMED THAT THERE WERE NO DEFECTS OR DAMAGE SEEN ON THE MACHINE OR BLOODLINE PRIOR TO THE EVENT. THE BMT WAS UNABLE TO REPORT HOW LONG INTO TREATMENT THE EVENT OCCURRED. PER BMT TREATMENT WAS IMMEDIATELY HALTED AND THE PATIENT¿S BLOOD WAS NOT RETURNED. THE BMT STATED THE ESTIMATED BLOOD LOSS WAS UNKNOWN. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE WHERE THE PATIENT WAS ABLE TO COMPLETE TREATMENT. THE BMT CONFIRMED THAT THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE BMT STATED THE COMPONENT WAS RETURNED FOR MANUFACTURER EVALUATION.
A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT THE BLOOD PUMP ROTOR TUBING GUIDE WAS LOOSE CAUSING DAMAGE TO THE BLOOD PUMP TUBING DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. UPON FOLLOW-UP, THE BMT STATED THE BLOOD PUMP ROTOR OF THE MACHINE, A FRESENIUS 2008T MACHINE, CUT OPEN THE BLOOD PUMP TUBING AND CAUSED A BLOOD LEAK TO OCCUR. THE BMT STATED THE ROTOR SLEEVES AROUND THE PINS WERE LOOSE AND SLIPPING OFF AND CAUSING THE BLOOD PUMP TO CUT THE TUBING. THE PREVIOUS ROTOR WAS THE ORIGINAL TO THE MACHINE. THE BMT STATED THE ROTOR LASTED 5,000 MACHINE HOURS BEFORE THE FAILURE OCCURRED. THE BMT ALSO STATED THAT FRESENIUS BLOODLINES WERE USED FOR TREATMENT AND CONFIRMED THAT THERE WERE NO DEFECTS OR DAMAGE SEEN ON THE MACHINE OR BLOODLINE PRIOR TO THE EVENT. THE BMT WAS UNABLE TO REPORT HOW LONG INTO TREATMENT THE EVENT OCCURRED. PER BMT TREATMENT WAS IMMEDIATELY HALTED AND THE PATIENT¿S BLOOD WAS NOT RETURNED. THE BMT STATED THE ESTIMATED BLOOD LOSS WAS UNKNOWN. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE WHERE THE PATIENT WAS ABLE TO COMPLETE TREATMENT. THE BMT CONFIRMED THAT THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE BMT STATED THE COMPONENT WAS RETURNED FOR MANUFACTURER EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1472825 | 2008T HD SYS. CDX W/BIBAG BLUE STAR | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | CONCORD MANUFACTURING | 191126 | 00840861102099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | FRESENIUS BLOODLINES.| FRESENIUS BLOODLINES.| FRESENIUS DIALYZER.| FRESENIUS DIALYZER. |