2008T HD SYS. W/O CDX W/BIBAG BLUE STAR
Report
- Report Number
- 0002937457-2022-02050
- Event Type
- Malfunction
- Date Received
- November 23, 2022
- Date of Event
- November 18, 2022
- Report Date
- January 18, 2023
- Manufacturer
- CONCORD MANUFACTURING
- Product Code
- KDI
- UDI-DI
- 00840861102112
- PMA / PMN Number
- K173972
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
CORRECTION: H6 DEVICE COMPONENT CODE.
ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: THE BLOOD PUMP ROTOR WAS RETURNED WITH ONE OF THE REAR GUIDE SHEAVES (POLYMER SLEEVE) LOOSE AND DEFORMED. THE SLEEVE CAN BE EASILY SLIDE OUT FROM THE PIN. THERE ARE NO DISCREPANCIES WITH THE OTHER THREE GUIDE PINS AND SLEEVES. INSERT THE REAR SLEEVE BACK ONTO THE GUIDE PIN AND INSTALL THE 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 RETURNED ROTOR DID NOT DAMAGE THE BLOODLINE AND NO FLUID LEAK OCCURRED DURING TESTING. THE REPORTED ¿HIGH (NEGATIVE) TMP¿ DID NOT OCCUR. THE REAR SLEEVE REMAINED INTACT AND DID NOT SLIDE OUT FROM THE PIN. THERE WAS NO ADDITIONAL DAMAGE TO THE SLEEVE 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.
PLANT INVESTIGATION: ALTHOUGH IT WAS STATED THAT THE COMPLAINT DEVICE WAS AVAILABLE TO BE RETURNED, TO DATE 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. INVESTIGATION DETERMINES THAT THERE WAS CAUSAL RELATIONSHIP BETWEEN THE OBJECTIVE EVIDENCE AND THE ALLEGED EVENT; THE ALLEGED EVENT IS CONFIRMED. 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 CONFIRMED.
CORRECTION: H6 DEVICE COMPONENT CODE.
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
A USER FACILITY CLINICAL COORDINATOR (CC) REPORTED THAT THE PLASTIC COVER ON THE ROTOR WAS DEFORMED AND THERE WAS A HIGH TMP ALARM. THE CC STATED THE ARTERIAL BLOOD LINE WAS CUT BY THE BLOOD PUMP ROTOR RESULTING IN BLOOD LOSS TWENTY MINUTES AFTER INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. UPON FOLLOW-UP, THE CC STATED THE BLOOD PUMP ROTOR OF THE MACHINE, A FRESENIUS 2008T MACHINE, SLIT OPEN THE BLOOD PUMP TUBING AND CAUSED THE BLOOD LEAK TO OCCUR. THE CC STATED THE PLASTIC COVER ON THE ROTOR WAS DEFORMED AND CUT THE ARTERIAL TUBING LINE. THE CC 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. PER CC TREATMENT WAS IMMEDIATELY HALTED AND THE PATIENT¿S BLOOD WAS NOT RETURNED. THE CC STATED THE ESTIMATED BLOOD LOSS WAS 250 ML. 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 CC STATED THE MACHINE ROTOR WAS REPLACED BY THE BIOMEDICAL TECHNICIAN AND THE MACHINE WAS PLACED BACK IN SERVICE. THE CC CONFIRMED THAT THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE CC STATED THE COMPONENT WAS AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.
A USER FACILITY CLINICAL COORDINATOR (CC) REPORTED THAT THE PLASTIC COVER ON THE ROTOR WAS DEFORMED AND THERE WAS A HIGH TMP ALARM. THE CC STATED THE ARTERIAL BLOOD LINE WAS CUT BY THE BLOOD PUMP ROTOR RESULTING IN BLOOD LOSS TWENTY MINUTES AFTER INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. UPON FOLLOW-UP, THE CC STATED THE BLOOD PUMP ROTOR OF THE MACHINE, A FRESENIUS 2008T MACHINE, SLIT OPEN THE BLOOD PUMP TUBING AND CAUSED THE BLOOD LEAK TO OCCUR. THE CC STATED THE PLASTIC COVER ON THE ROTOR WAS DEFORMED AND CUT THE ARTERIAL TUBING LINE. THE CC 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. PER CC TREATMENT WAS IMMEDIATELY HALTED AND THE PATIENT¿S BLOOD WAS NOT RETURNED. THE CC STATED THE ESTIMATED BLOOD LOSS WAS 250 ML. 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 CC STATED THE MACHINE ROTOR WAS REPLACED BY THE BIOMEDICAL TECHNICIAN AND THE MACHINE WAS PLACED BACK IN SERVICE. THE CC CONFIRMED THAT THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE CC STATED THE COMPONENT WAS AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.
A USER FACILITY CLINICAL COORDINATOR (CC) REPORTED THAT THE PLASTIC COVER ON THE ROTOR WAS DEFORMED AND THERE WAS A HIGH TMP ALARM. THE CC STATED THE ARTERIAL BLOOD LINE WAS CUT BY THE BLOOD PUMP ROTOR RESULTING IN BLOOD LOSS TWENTY MINUTES AFTER INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. UPON FOLLOW-UP, THE CC STATED THE BLOOD PUMP ROTOR OF THE MACHINE, A FRESENIUS 2008T MACHINE, SLIT OPEN THE BLOOD PUMP TUBING AND CAUSED THE BLOOD LEAK TO OCCUR. THE CC STATED THE PLASTIC COVER ON THE ROTOR WAS DEFORMED AND CUT THE ARTERIAL TUBING LINE. THE CC 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. PER CC TREATMENT WAS IMMEDIATELY HALTED AND THE PATIENT¿S BLOOD WAS NOT RETURNED. THE CC STATED THE ESTIMATED BLOOD LOSS WAS 250 ML. 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 CC STATED THE MACHINE ROTOR WAS REPLACED BY THE BIOMEDICAL TECHNICIAN AND THE MACHINE WAS PLACED BACK IN SERVICE. THE CC CONFIRMED THAT THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE CC STATED THE COMPONENT WAS AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.
A USER FACILITY CLINICAL COORDINATOR (CC) REPORTED THAT THE PLASTIC COVER ON THE ROTOR WAS DEFORMED AND THERE WAS A HIGH TMP ALARM. THE CC STATED THE ARTERIAL BLOOD LINE WAS CUT BY THE BLOOD PUMP ROTOR RESULTING IN BLOOD LOSS TWENTY MINUTES AFTER INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. UPON FOLLOW-UP, THE CC STATED THE BLOOD PUMP ROTOR OF THE MACHINE, A FRESENIUS 2008T MACHINE, SLIT OPEN THE BLOOD PUMP TUBING AND CAUSED THE BLOOD LEAK TO OCCUR. THE CC STATED THE PLASTIC COVER ON THE ROTOR WAS DEFORMED AND CUT THE ARTERIAL TUBING LINE. THE CC 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. PER CC TREATMENT WAS IMMEDIATELY HALTED AND THE PATIENT¿S BLOOD WAS NOT RETURNED. THE CC STATED THE ESTIMATED BLOOD LOSS WAS 250 ML. 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 CC STATED THE MACHINE ROTOR WAS REPLACED BY THE BIOMEDICAL TECHNICIAN AND THE MACHINE WAS PLACED BACK IN SERVICE. THE CC CONFIRMED THAT THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE CC STATED THE COMPONENT WAS AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.
A USER FACILITY CLINICAL COORDINATOR (CC) REPORTED THAT THE PLASTIC COVER ON THE ROTOR WAS DEFORMED AND THERE WAS A HIGH TMP ALARM. THE CC STATED THE ARTERIAL BLOOD LINE WAS CUT BY THE BLOOD PUMP ROTOR RESULTING IN BLOOD LOSS TWENTY MINUTES AFTER INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. UPON FOLLOW-UP, THE CC STATED THE BLOOD PUMP ROTOR OF THE MACHINE, A FRESENIUS 2008T MACHINE, SLIT OPEN THE BLOOD PUMP TUBING AND CAUSED THE BLOOD LEAK TO OCCUR. THE CC STATED THE PLASTIC COVER ON THE ROTOR WAS DEFORMED AND CUT THE ARTERIAL TUBING LINE. THE CC 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. PER CC TREATMENT WAS IMMEDIATELY HALTED AND THE PATIENT¿S BLOOD WAS NOT RETURNED. THE CC STATED THE ESTIMATED BLOOD LOSS WAS 250 ML. 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 CC STATED THE MACHINE ROTOR WAS REPLACED BY THE BIOMEDICAL TECHNICIAN AND THE MACHINE WAS PLACED BACK IN SERVICE. THE CC CONFIRMED THAT THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE CC STATED THE COMPONENT WAS AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240171 | 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 | 58 YR | Female | FRESENIUS BLOODLINES.| FRESENIUS BLOODLINES.| FRESENIUS BLOODLINES.| FRESENIUS BLOODLINES.| FRESENIUS BLOODLINES.| FRESENIUS DIALYZER.| FRESENIUS DIALYZER.| FRESENIUS DIALYZER.| FRESENIUS DIALYZER.| FRESENIUS DIALYZER. |