2008T HD SYS. W/O CDX W/BIBAG BLUE STAR
Report
- Report Number
- 0002937457-2023-00049
- Event Type
- Malfunction
- Date Received
- January 11, 2023
- Date of Event
- January 9, 2023
- Report Date
- March 3, 2023
- 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: D9, H3 PLANT INVESTIGATION: THE ROTOR WAS RETURNED AND SHOWED ONE OF THE REAR GUIDE SHEAVE (POLYMER SLEEVE) DEFORMED AND LOOSE. THE SLEEVE CAN BE REMOVED FROM THE GUIDE PIN. THE GUIDE PIN APPEARS TO HAVE DEBRIS AND WEAR MARKINGS. THE OTHER REAR PIN IS MISSING A SLEEVE WITH WEAR MARKINGS. THERE ARE NO DISCREPANCIES WITH THE TWO FRONT GUIDE PIN AND SLEEVE. INSTALLED 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 (BLOOD PUMP RATE SET AT 450 ML/MIN) FOR 3 HOURS. THE ROTOR DID NOT DAMAGE THE BLOODLINE AND THERE WERE NO FLUID LEAKS OR ALARMS DURING TESTING. THE DEFECTIVE REAR SLEEVE DID NOT DISLODGE FROM THE PIN. THERE WAS NO FURTHER DAMAGE OCCURRED TO THE ROTOR DURING TESTING. 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 BE CONFIRMED.
PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. INVESTIGATION DETERMINES THAT THERE WAS CAUSAL RELATIONSHIP BETWEEN THE OBJECTIVE EVIDENCE AND THE ALLEGED EVENT; THE ALLEGED EVENT IS CONFIRMED. A PRODUCT HISTORY REVIEW WAS COMPLETED DURING THE INVESTIGATION. 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 BE 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 DAMAGED THE BLOOD PUMP TUBING SEGMENT AND CAUSED BLOOD TO LEAK DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT WITH A BLOOD LOSS OF ABOUT 100CC OF BLOOD. UPON FOLLOW-UP, THE BMT STATED THE BLOOD PUMP ROTOR OF THE MACHINE, A FRESENIUS 2008T MACHINE, CAME OFF AND CAUSED A BLOOD LEAK TO OCCUR. THE BMT STATED THE ROTOR GUIDE SLEEVES (AROUND THE PINS) CAME OFF AND CUT THE BLOOD PUMP TUBING. THE MACHINE WAS PULLED FROM SERVICE PENDING REPLACEMENT OF THE BLOOD PUMP ROTOR. THE ROTOR WAS THE ORIGINAL TO THE MACHINE. THE BMT STATED THE ROTOR LASTED 4716 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 APPROXIMATELY 100CC. 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 AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.
A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT THE BLOOD PUMP ROTOR DAMAGED THE BLOOD PUMP TUBING SEGMENT AND CAUSED BLOOD TO LEAK DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT WITH A BLOOD LOSS OF ABOUT 100CC OF BLOOD. UPON FOLLOW-UP, THE BMT STATED THE BLOOD PUMP ROTOR OF THE MACHINE, A FRESENIUS 2008T MACHINE, CAME OFF AND CAUSED A BLOOD LEAK TO OCCUR. THE BMT STATED THE ROTOR GUIDE SLEEVES (AROUND THE PINS) CAME OFF AND CUT THE BLOOD PUMP TUBING. THE MACHINE WAS PULLED FROM SERVICE PENDING REPLACEMENT OF THE BLOOD PUMP ROTOR. THE ROTOR WAS THE ORIGINAL TO THE MACHINE. THE BMT STATED THE ROTOR LASTED 4716 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 APPROXIMATELY 100CC. 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 AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.
A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT THE BLOOD PUMP ROTOR DAMAGED THE BLOOD PUMP TUBING SEGMENT AND CAUSED BLOOD TO LEAK DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT WITH A BLOOD LOSS OF ABOUT 100CC OF BLOOD. UPON FOLLOW-UP, THE BMT STATED THE BLOOD PUMP ROTOR OF THE MACHINE, A FRESENIUS 2008T MACHINE, CAME OFF AND CAUSED A BLOOD LEAK TO OCCUR. THE BMT STATED THE ROTOR GUIDE SLEEVES (AROUND THE PINS) CAME OFF AND CUT THE BLOOD PUMP TUBING. THE MACHINE WAS PULLED FROM SERVICE PENDING REPLACEMENT OF THE BLOOD PUMP ROTOR. THE ROTOR WAS THE ORIGINAL TO THE MACHINE. THE BMT STATED THE ROTOR LASTED 4716 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 APPROXIMATELY 100CC. 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 AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1471816 | 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | CONCORD MANUFACTURING | 191130 | 00840861102112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | FRESENIUS BLOODLINES| FRESENIUS BLOODLINES| FRESENIUS BLOODLINES| FRESENIUS DIALYZER| FRESENIUS DIALYZER| FRESENIUS DIALYZER |