OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Report
- Report Number
- 0001713747-2024-00284
- Event Type
- Malfunction
- Date Received
- April 8, 2024
- Date of Event
- March 22, 2024
- Report Date
- May 16, 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
- NURSE
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: PLANT INVESTIGATION: THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE CORPORATE PROVIDED BLOOD PORT AND ADAPTER CAPS WERE ATTACHED TO THE DEVICE. THE FIBERS WITHIN THE DIALYZER WERE WET. DURING GROSS VISUAL EXAMINATION, TWO POTTED FIBER FRAGMENTS WERE OBSERVED ON THE NON-CAVITY ID END AT APPROXIMATELY 150°, WITH THE DIALYSATE PORTS POSITIONED AT 0°. ONE OF THE FIBER FRAGMENTS WAS APPROXIMATELY 0.22 MM IN LENGTH ABOVE THE POLYURETHANE (PU) SURFACE, AND THE OTHER FIBER FRAGMENT WAS FLUSH WITH THE PU SURFACE. THE OPPOSING ENDS WERE NOT IDENTIFIED. FURTHER EXAMINATION OF THE COMPLAINT DEVICE DID NOT IDENTIFY ANY OTHER DAMAGE OR IRREGULARITIES. THE DIALYZER WAS NOT SUBJECTED TO A LEAK TEST AS POTTED FIBER FRAGMENTS ARE KNOWN TO IMPACT THE INTEGRITY OF THE DIALYZER. A PRODUCTION RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS THEN CONDUCTED BY THE MANUFACTURER. THERE WERE MULTIPLE APPROVED TEMPORARY DEVIATION NOTICES (DNS) AND A NON-CONFORMANCE (NC) IN THE PRODUCTION OF THIS LOT. THEY WERE ALL UNRELATED TO THE COMPLAINT EVENT. THERE WAS NO INDICATION OF PRODUCT NONACCEPTANCE, DEVIATION, NC, REWORK, LABELING OR PROCESS CONTROL FAILURE DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE LOT MET ALL RELEASE CRITERIA. THE INVESTIGATION INTO THE COMPLAINT WAS ABLE TO CONFIRM THE REPORTED EVENT. CONTINUOUS IMPROVEMENT IS OF THE UTMOST IMPORTANCE TO FRESENIUS MEDICAL CARE AS WE STRIVE TO PROVIDE DIALYSIS PRODUCTS OF THE HIGHEST QUALITY TO OUR PATIENTS. REPORTS OF LEAKING PRODUCT ARE INVESTIGATED BOTH INDIVIDUALLY AS COMPLAINTS, AS WELL AS VIA THE NC/CAPA PROGRAM, IN ORDER TO ASSESS AND IMPROVE OUR PRODUCTS AND PROCESSES. CAPAS FOR VISION SYSTEMS AND BLOOD LEAK REDUCTION ARE RECENT EXAMPLES OF LEAK RELATED INVESTIGATIONS DIRECTED AT AN OVERALL REDUCTION IN DIALYZER LEAKS.
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
A USER FACILITY CLINICAL MANAGER (CM) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK OCCURRED AT THE VERY BEGINNING OF TREATMENT. THE CM STATED THE BLOOD LEAK WAS VISIBLE WITHIN THE DIALYZER, OUTSIDE OF THE FIBERS. BLOOD WAS PARTICULARLY APPARENT WITHIN THE ARTERIAL HEADER OF THE DEVICE. BLOOD WAS ALSO SEEN IN THE EFFLUENT/DRAIN LINE. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. THE DIALYSATE WAS TESTED WITH A BLOOD TEST STRIP, AND IT TESTED POSITIVE FOR BLOOD. THERE WAS NO PHYSICAL DAMAGE NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE ALSO BEING USED. AFTER THE LEAK OCCURRED, THE TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS 300 ML. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE COMPLAINT DEVICE WAS CONFIRMED TO BE AVAILABLE FOR MANUFACTURER EVALUATION.
A USER FACILITY CLINICAL MANAGER (CM) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK OCCURRED AT THE VERY BEGINNING OF TREATMENT. THE CM STATED THE BLOOD LEAK WAS VISIBLE WITHIN THE DIALYZER, OUTSIDE OF THE FIBERS. BLOOD WAS PARTICULARLY APPARENT WITHIN THE ARTERIAL HEADER OF THE DEVICE. BLOOD WAS ALSO SEEN IN THE EFFLUENT/DRAIN LINE. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. THE DIALYSATE WAS TESTED WITH A BLOOD TEST STRIP, AND IT TESTED POSITIVE FOR BLOOD. THERE WAS NO PHYSICAL DAMAGE NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE ALSO BEING USED. AFTER THE LEAK OCCURRED, THE TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS 300 ML. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE COMPLAINT DEVICE WAS CONFIRMED TO BE AVAILABLE FOR MANUFACTURER EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 418823 | OPTIFLUX 180NRE DIALYZER FINISHED ASSY. | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | OGDEN MANUFACTURING PLANT | 23SU02013 | 00840861100156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Female | FRESENIUS 2008T MACHINE| FRESENIUS 2008T MACHINE| FRESENIUS BLOODLINES| FRESENIUS BLOODLINES |