OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
Report
- Report Number
- 0001713747-2023-00005
- Event Type
- Malfunction
- Date Received
- January 4, 2023
- Date of Event
- December 16, 2022
- Report Date
- March 2, 2023
- Manufacturer
- OGDEN MANUFACTURING PLANT
- Product Code
- KDI
- UDI-DI
- 00840861100149
- PMA / PMN Number
- K162488
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
PLANT INVESTIGATION: THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE DEVICE WAS RETURNED WITH THE CORPORATE PROVIDED BLOOD PORT AND ADAPTER CAPS ATTACHED. BLOOD RESIDUE WAS PRESENT THROUGHOUT THE FIBERS, AND COAGULATED BLOOD WAS PRESENT IN BOTH HEADER CAPS. THERE WAS ALSO BLOOD ON THE OUTSIDE OF THE DIALYZER, HOWEVER, THIS MAY BE FROM WHEN THE BLOODLINES WERE REMOVED. DURING GROSS VISUAL EXAMINATION, A POTTED FIBER FRAGMENT WAS OBSERVED ON THE NON-CAVITY ID END AT APPROXIMATELY 350° WITH THE DIALYSATE PORTS SITUATED AT 0°. THE FIBER FRAGMENT WAS APPROXIMATELY 0.17MM IN LENGTH, AND THE OPPOSING END WAS NOT IDENTIFIED. NO OTHER DAMAGE OR IRREGULARITIES WERE FOUND ON THE SAMPLE. 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 WAS ONE APPROVED TEMPORARY DEVIATION NOTICE (DN) REPORTED ON THE LOT WHICH WAS UNRELATED TO THE COMPLAINT EVENT. 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. THE LEAK WAS CONFIRMED DUE TO A POTTED FIBER FRAGMENT. THE PROBABLE CAUSES FOR THIS FAILURE TO OCCUR ARE RELATED TO THE HANDLING OF THE FIBER BUNDLE DURING PRODUCTION AND DURING THE INSERTION PROCESS OF THE FIBER BUNDLE INTO THE DIALYZER HOUSING. 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 CORPORATE MANAGER OF INVENTORY REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED AT A HEMODIALYSIS (HD) CLINIC. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH A NURSE FROM THE CLINIC WHO WAS FAMILIAR WITH THE EVENT. THE NURSE SAID THE DIALYZER BLOOD LEAK WAS INTERNAL, AND VISUALLY OBSERVED IN THE DIALYSATE COMPARTMENT OF THE DEVICE. THE BLOOD LEAK OCCURRED IMMEDIATELY AT THE ONSET OF HD TREATMENT. A BLOOD TEST STRIP WAS NOT USED; THE NURSE STATED IT WAS OBVIOUS THAT A BLOOD LEAK HAD OCCURRED. IT WAS CONFIRMED THAT THE MACHINE, A FRESENIUS 2008K2, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. NO PHYSICAL DAMAGE WAS OBSERVED ON THE DIALYZER. FRESENIUS BLOODLINES WERE BEING UTILIZED FOR THE TREATMENT. AFTER THE MACHINE ALARMED, THE TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS 250 ML. THE NURSE 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 DIALYZER WAS AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.
A CORPORATE MANAGER OF INVENTORY REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED AT A HEMODIALYSIS (HD) CLINIC. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH A NURSE FROM THE CLINIC WHO WAS FAMILIAR WITH THE EVENT. THE NURSE SAID THE DIALYZER BLOOD LEAK WAS INTERNAL, AND VISUALLY OBSERVED IN THE DIALYSATE COMPARTMENT OF THE DEVICE. THE BLOOD LEAK OCCURRED IMMEDIATELY AT THE ONSET OF HD TREATMENT. A BLOOD TEST STRIP WAS NOT USED; THE NURSE STATED IT WAS OBVIOUS THAT A BLOOD LEAK HAD OCCURRED. IT WAS CONFIRMED THAT THE MACHINE, A FRESENIUS 2008K2, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. NO PHYSICAL DAMAGE WAS OBSERVED ON THE DIALYZER. FRESENIUS BLOODLINES WERE BEING UTILIZED FOR THE TREATMENT. AFTER THE MACHINE ALARMED, THE TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS 250 ML. THE NURSE 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 DIALYZER WAS AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1333251 | OPTIFLUX 160NRE DIALYZER FINISHED ASSY. | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | OGDEN MANUFACTURING PLANT | 0500316E | 22PU06002 | 00840861100149 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Female | FRESENIUS 2008K2 MACHINE| FRESENIUS 2008K2 MACHINE| FRESENIUS BLOODLINES| FRESENIUS BLOODLINES |