OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Report
- Report Number
- 0001713747-2024-00647
- Event Type
- Malfunction
- Date Received
- August 22, 2024
- Date of Event
- August 10, 2024
- Report Date
- October 9, 2024
- Manufacturer
- OGDEN MANUFACTURING PLANT
- Product Code
- KDI
- UDI-DI
- 00840861100156
- PMA / PMN Number
- K162488
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- 501
Narratives
PLANT INVESTIGATION: THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: THE REPORTED COMPLAINT WAS NOT CONFIRMED AS THE COMPLAINT DEVICE WAS NOT RETURNED FOR MANUFACTURER EVALUATION. DURING THE LOT HISTORY REVIEW IT WAS NOTED THAT THERE WAS ON OTHER COMPLAINT REPORTED AGAINST THE LOT. THE COMPLAINT IS NOT ASSOCIATED WITH THE CURRENT EVENT. THE NUMBER OF COMPLAINTS FOR THE ASSIGNED SYMPTOM CODE ON THE LOT NUMBER WAS REVIEWED AND IT WAS DETERMINED THAT NO LOT COMPLAINT EXCURSION OCCURRED. A PRODUCTION RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED BY THE MANUFACTURER. THERE WAS NO INDICATION OF PRODUCT NONACCEPTANCE, DEVIATION, NON-CONFORMANCE, REWORK, LABELING OR PROCESS CONTROL FAILURE DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE LOT MET ALL RELEASE CRITERIA. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT PHYSICAL EXAMINATION OF THE ACTUAL DEVICE. THEREFORE, THE COMPLAINT IS NOT CONFIRMED. CAPAS FOR VISION SYSTEMS AND BLOOD LEAK REDUCTION ARE RECENT EXAMPLES OF LEAK RELATED INVESTIGATIONS DIRECTED AT AN OVERALL REDUCTION IN DIALYZER LEAKS.
A USER FACILITY CHARGE NURSE (CN) STATED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT AND WHEN ATTEMPTING TO RECIRCULATE THE LINE, THE DIALYZER WAS FLIPPED FOR THE RED CONNECTOR TO BE UP FOR DIALYSATE TO FILL UP THE DIALYZER. THE DIALYZER WAS THEN FLIPPED BACK AGAIN FOR THE BLUE CONNECTOR TO BE UP AND THE RED COLOR WAS NOTED AT THE RED HENSON LINE. UPON FOLLOW-UP, THE CN CONFIRMED THE REPORTED EVENT AND STATED AN INTERNAL DIALYZER BLOOD LEAK OCCURRED LESS THAN FIVE MINUTES AFTER INITIATION OF HEMODIALYSIS TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED WITHIN THE DIALYZER HOUSING BY THE RED HANSEN LINE. THE FRESENIUS 2008T HEMODIALYSIS MACHINE ALARMED APPROPRIATELY WITH A BLOOD LEAK ALERT. BLOOD LEAK TEST STRIPS WERE NOT USED AS THE BLOOD LEAK WAS VISUALLY CONFIRMED. FRESENIUS BLOODLINES WERE USED FOR THE TREATMENT. THERE WAS NO REPORTED DAMAGE IDENTIFIED ON THE DIALYZER. AFTER THE MACHINE ALARMED, TREATMENT WAS HALTED; THE PATIENT¿S BLOOD WAS NOT RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 200 ML. IT WAS CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS ABLE TO COMPLETE TREATMENT AFTER BEING SET UP WITH NEW SUPPLIES A DIFFERENT MACHINE. THE DIALYZER WAS AVAILABLE TO BE RETURNED FOR EVALUATION.
A USER FACILITY CHARGE NURSE (CN) STATED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT AND WHEN ATTEMPTING TO RECIRCULATE THE LINE, THE DIALYZER WAS FLIPPED FOR THE RED CONNECTOR TO BE UP FOR DIALYSATE TO FILL UP THE DIALYZER. THE DIALYZER WAS THEN FLIPPED BACK AGAIN FOR THE BLUE CONNECTOR TO BE UP AND THE RED COLOR WAS NOTED AT THE RED HENSON LINE. UPON FOLLOW-UP, THE CN CONFIRMED THE REPORTED EVENT AND STATED AN INTERNAL DIALYZER BLOOD LEAK OCCURRED LESS THAN FIVE MINUTES AFTER INITIATION OF HEMODIALYSIS TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED WITHIN THE DIALYZER HOUSING BY THE RED HANSEN LINE. THE FRESENIUS 2008T HEMODIALYSIS MACHINE ALARMED APPROPRIATELY WITH A BLOOD LEAK ALERT. BLOOD LEAK TEST STRIPS WERE NOT USED AS THE BLOOD LEAK WAS VISUALLY CONFIRMED. FRESENIUS BLOODLINES WERE USED FOR THE TREATMENT. THERE WAS NO REPORTED DAMAGE IDENTIFIED ON THE DIALYZER. AFTER THE MACHINE ALARMED, TREATMENT WAS HALTED; THE PATIENT¿S BLOOD WAS NOT RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 200 ML. IT WAS CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS ABLE TO COMPLETE TREATMENT AFTER BEING SET UP WITH NEW SUPPLIES A DIFFERENT MACHINE. THE DIALYZER WAS AVAILABLE TO BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1013139 | OPTIFLUX 180NRE DIALYZER FINISHED ASSY. | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | OGDEN MANUFACTURING PLANT | 24EU07007 | 00840861100156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | FRESENIUS 2008T MACHINE| FRESENIUS 2008T MACHINE| FRESENIUS BLOODLINES| FRESENIUS BLOODLINES |