ULTRAFLUX AV 600 S
Report
- Report Number
- 3002807005-2022-00002
- Event Type
- Malfunction
- Date Received
- February 11, 2022
- Date of Event
- December 1, 2021
- Report Date
- December 5, 2022
- Manufacturer
- FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
- Product Code
- KDI
- PMA / PMN Number
- K002761
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
CORRECTION: D3, G1 PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. DURING THE REVIEW, THERE WAS NO INDICATION FOR ANY RELATIONSHIP WITH THE REPORTED FAILURE MODE. ALL RELEASED PRODUCTS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS. THE MANUFACTURER COULD NOT PERFORM ANY FURTHER ANALYSIS BECAUSE THE COMPLAINT DEVICE WAS NOT AVAILABLE, AND NO SUPPORTING PHOTOS WERE PROVIDED. DUE TO 100% TESTING, IT IS HIGHLY UNLIKELY TO DETECT A FAILURE IN A RETENTION SAMPLE. FURTHERMORE, ONLY A SMALL NUMBER OF RESERVE SAMPLES ARE AVAILABLE. THEREFORE, THE RETENTION SAMPLE ANALYSIS WAS NOT DONE. THE DESCRIBED SITUATION IS ADEQUATELY ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU) AND/OR ON THE LABEL. AS THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION AND MACHINE FILES WERE NOT PROVIDED FOR REVIEW, THE ROOT CAUSE OF THE DIALYZER CLOGGING COULD NOT BE CONFIRMED.
ADDITIONAL INFORMATION: B5, H10 CORRECTION: D10, E1, G2, H6 THE PLANT INVESTIGATION IS STILL IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL REVIEW: IN THE INFORMATION PROVIDED, THOUGH LABORATORY VALUES PRESENTED IN SEVERE RANGES, THERE WAS NO INDICATION THIS PATIENT EXPERIENCED AN ADVERSE EVENT OR SERIOUS INJURY RELATED TO THE ABNORMAL LABORATORY VALUES. ADDITIONALLY, MEDICAL INTERVENTION FOR THIS EVENT INCLUDED CHANGING THE FILTER AND DISPOSABLES, YET IT WAS STATED THIS WAS DONE TO NORMALIZE LABORATORY VALUES WITH NO INDICATION THIS EXCHANGE WAS TO REVERSE ANY HARMFUL EFFECTS OF THE SUSPECTED CLOGGING. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF A SERIOUS INJURY, PATIENT DEATH, OR OTHER ADVERSE EVENT RELATED TO A FRESENIUS PRODUCT OR OTHER ISSUE WARRANTING FURTHER INVESTIGATION.
IT WAS REPORTED THAT SEVERELY ILL PATIENTS (SOFA SCORE IN THE RANGE OF 14 PTS) SHOWED A POORER PERFORMANCE DUE TO SEVERE CLOGGING OF THE DIALYZER. THE CLOGGING LED TO TECHNICAL MALFUNCTIONS OF THE MULTIFILTRATEPRO MACHINE (EMPTYING OF THE HEATING BAG DURING TREATMENT) AND SERIOUS CHANGES IN THE PATIENT'S BLOOD VALUES (BICARBONATE AND SODIUM LEVELS IN ABGA). THE NEGATIVE CHANGES IN BLOOD VALUES MADE IT NECESSARY TO REPLACE THE KIT. THE PHENOMENON USUALLY OCCURRED WITHIN THE FIRST 16 HOURS OF TREATMENT. THE COMPLAINT DEVICE WAS CONFIRMED TO BE DISCARDED AND NOT AVAILABLE TO BE RETURNED FOR PHYSICAL EVALUATION. FURTHER PATIENT INFORMATION, INCLUDING THE NUMBER OF PATIENTS INVOLVED, DIAGNOSES, INDICATION FOR CHRONIC KIDNEY RENAL THERAPY (CKRT), TREATMENT PARAMETERS, MACHINE DATA, PARALLEL TREATMENTS/MEDICATIONS, AND BLOOD CHEMISTRY ARE NOT AVAILABLE.
THE FINAL MANUFACTURER INCIDENT REPORT (MIR) WAS REVIEWED, AND IT WAS FOUND THAT THE LOCAL FRESENIUS MEDICAL CARE ORGANIZATION RECEIVED A REPORT REGARDING A POTENTIAL CLOGGING EVENT THAT OCCURRED WITHIN 16 HOURS OF THIS PATIENT¿S CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED AND THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) VOLUME DUE TO THE CLOGGING WAS UNKNOWN. IT WAS STATED THERE WAS A CLEAR TECHNICAL FAILURE OF THE MULITFILTRATEPRO AS THERE WAS AN EMPTYING OF THE HEATER BAG DURING THE CRRT TREATMENT. FOLLOWING THIS TECHNICAL FAILURE, THE PATIENT¿S BICARBONATE (HCO3-) INCREASED TO 40 MMOL/L AND NA+ INCREASED ABOVE 150 MEQ/L. THIS EVENT NECESSITATED A CHANGE IN THE FILTER AND ASSOCIATED DISPOSABLES. ADDITIONAL ATTEMPTS MADE BY FRESENIUS MEDICAL CARE (SCHWEIZ) AG TO OBTAIN PATIENT INFORMATION, FURTHER DETAILS OF THIS EVENT, TREATMENT DATA, CAUSALITY AND CURRENT DISPOSITION OF THIS PATIENT PROVED UNSUCCESSFUL.
THE FINAL MANUFACTURER INCIDENT REPORT (MIR) WAS REVIEWED, AND IT WAS FOUND THAT THE LOCAL FRESENIUS MEDICAL CARE ORGANIZATION RECEIVED A REPORT REGARDING A POTENTIAL CLOGGING EVENT THAT OCCURRED WITHIN 16 HOURS OF THIS PATIENT¿S CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED AND THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) VOLUME DUE TO THE CLOGGING WAS UNKNOWN. IT WAS STATED THERE WAS A CLEAR TECHNICAL FAILURE OF THE MULITFILTRATEPRO AS THERE WAS AN EMPTYING OF THE HEATER BAG DURING THE CRRT TREATMENT. FOLLOWING THIS TECHNICAL FAILURE, THE PATIENT¿S BICARBONATE (HCO3-) INCREASED TO 40 MMOL/L AND NA+ INCREASED ABOVE 150 MEQ/L. THIS EVENT NECESSITATED A CHANGE IN THE FILTER AND ASSOCIATED DISPOSABLES. ADDITIONAL ATTEMPTS MADE BY FRESENIUS MEDICAL CARE (SCHWEIZ) AG TO OBTAIN PATIENT INFORMATION, FURTHER DETAILS OF THIS EVENT, TREATMENT DATA, CAUSALITY AND CURRENT DISPOSITION OF THIS PATIENT PROVED UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 90218 | ULTRAFLUX AV 600 S | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH | C2BA13100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | MULTIFILTRATEPRO MACHINE| MULTIFILTRATEPRO MACHINE |