2008T HEMODIALYSIS SYS., WITH CDX
Report
- Report Number
- 0002937457-2023-01038
- Event Type
- Malfunction
- Date Received
- July 18, 2023
- Date of Event
- July 12, 2023
- Report Date
- August 3, 2023
- Manufacturer
- CONCORD MANUFACTURING
- Product Code
- KDI
- UDI-DI
- 00840861100897
- PMA / PMN Number
- K150708
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
ADDITIONAL INFORMATION D9 AND H3. PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, AN ON-SITE EVALUATION WAS PERFORMED BY A FRESENIUS BIOMEDICAL TECHNICIAN (BMET). TO RESOLVE THE REPORTED ISSUE, THE BMET REPLACED THE BLOOD PUMP ROTOR ON THE MACHINE. 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 BMET IDENTIFIED A TUBING GUIDE ROLLER ON THE BLOOD PUMP, THAT TORE THROUGH THE BLOODLINES, CAUSING A BLOOD LEAK TO OCCUR. THEREFORE, THE COMPLAINT EVENT WAS CONFIRMED.
A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT THE TUBING GUIDE ROLLER ON THE BLOOD PUMP ROTOR OF THE 2008T MACHINE, TORE THROUGH THE FRESENIUS COMBI SET BLOODLINES DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT, CAUSING A BLOOD LEAK TO OCCUR. A USER FACILITY REGISTERED NURSE (RN) CONFIRMED THE REPORTED EVENT DURING FOLLOW-UP. THE RN STATED THAT THE EVENT OCCURRED TOWARDS THE END OF THE PATIENT¿S TREATMENT AND THE MACHINE DID PROVIDE AIR DETECTED ALARMS TO ALERT THE STAFF TO THE ISSUE. THE RN STATED THAT THE ISSUE WAS DISCOVERED WHEN IT WAS VISUALLY OBSERVED BY THE MEDICAL STAFF. THERE WAS NO DEFECT OR DAMAGE NOTED TO THE BLOODLINES PRIOR TO THE OCCURRENCE OF THIS ISSUE. THE RN STATED THAT THE BLOODLINES APPEARED TO HAVE BEEN TORN BY THE MACHINE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT SUCCESSFULLY COMPLETED TREATMENT ON A DIFFERENT MACHINE WITH NEW SUPPLIES. THE BIOMED STATED THAT THE BLOOD PUMP ROTOR WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE HAS BEEN RETURNED TO SERVICE. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED FOR PHYSICAL EVALUATION BY THE MANUFACTURER.
A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT THE TUBING GUIDE ROLLER ON THE BLOOD PUMP ROTOR OF THE 2008T MACHINE, TORE THROUGH THE FRESENIUS COMBI SET BLOODLINES DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT, CAUSING A BLOOD LEAK TO OCCUR. A USER FACILITY REGISTERED NURSE (RN) CONFIRMED THE REPORTED EVENT DURING FOLLOW-UP. THE RN STATED THAT THE EVENT OCCURRED TOWARDS THE END OF THE PATIENT¿S TREATMENT AND THE MACHINE DID PROVIDE AIR DETECTED ALARMS TO ALERT THE STAFF TO THE ISSUE. THE RN STATED THAT THE ISSUE WAS DISCOVERED WHEN IT WAS VISUALLY OBSERVED BY THE MEDICAL STAFF. THERE WAS NO DEFECT OR DAMAGE NOTED TO THE BLOODLINES PRIOR TO THE OCCURRENCE OF THIS ISSUE. THE RN STATED THAT THE BLOODLINES APPEARED TO HAVE BEEN TORN BY THE MACHINE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT SUCCESSFULLY COMPLETED TREATMENT ON A DIFFERENT MACHINE WITH NEW SUPPLIES. THE BIOMED STATED THAT THE BLOOD PUMP ROTOR WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE HAS BEEN RETURNED TO SERVICE. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED FOR PHYSICAL EVALUATION BY THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 766984 | 2008T HEMODIALYSIS SYS., WITH CDX | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | CONCORD MANUFACTURING | 190713 | 00840861100897 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | FRESENIUS BLOODLINES| FRESENIUS BLOODLINES| FRESENIUS DIALYZER| FRESENIUS DIALYZER |