DIALYZER
Report
- Report Number
- 0001713747-2024-00762
- Event Type
- Malfunction
- Date Received
- September 23, 2024
- Date of Event
- September 7, 2024
- Report Date
- November 5, 2024
- Manufacturer
- OGDEN MANUFACTURING PLANT
- Product Code
- KDI
- PMA / PMN Number
- K162488
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
PLANT INVESTIGATION: THE REPORTED COMPLAINT WAS NOT CONFIRMED AS THE COMPLAINT DEVICE WAS NOT RETURNED FOR MANUFACTURER EVALUATION. AS NO LOT NUMBER WAS PROVIDED FOR THIS COMPLAINT, AN SEARCH WAS PERFORMED TO OBTAIN ALL LOT NUMBERS WITH THE REPORTED CATALOG NUMBER DELIVERED TO THE PATIENT¿S DIALYSIS UNIT IN THE THREE MONTHS PRIOR TO THE COMPLAINT OCCURRENCE DATE. TWENTY-FOUR WERE FOUND TO HAVE BEEN DELIVERED IN THIS TIME PERIOD. A PRODUCTION RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOTS. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED BY THE MANUFACTURER. THE PRODUCTION RECORD REVIEW SHOWED FOURTEEN OF THE TWENTY-FOUR IDENTIFIED LOTS HAD ONE TO MULTIPLE APPROVED TEMPORARY DEVIATIONS (DNS), AND THREE OF THOSE LOTS HAVE NON-CONFORMANCES (NCS). LOT 24DU06030 NC 1760563: A TEST RESULT WAS SIGNED FOR WITHOUT THE RESULT WRITTEN. LOT 23PU07023 NC 1604808: EXCEEDED DELAMINATION REJECT RATE OF 0.025% ACTUAL WAS 0.041% RESULTING IN REWORK. LOT 24EU01014 NC 1790143: COUNT DISCREPANCY. THERE WAS NO INDICATION OF PRODUCT NON-ACCEPTANCE OR DEVIATION IN THE MANUFACTURING PROCESS RELATED TO THE COMPLAINT EVENT. THIS INCLUDES LABELING, PROCESS CONTROLS, AND ANY OTHER OCCURRENCE IN PRODUCTION THAT WAS POTENTIALLY RELATED TO THE COMPLAINT. THE REPORTED LOT NUMBER PASSED PYROGEN TESTING, WAS WITHIN STERILIZATION DOSAGE PARAMETERS AND PASSED 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.
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
A USER FACILITY¿S INVENTORY MANAGER REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. IT IS UNKNOWN IF THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.
A USER FACILITY¿S INVENTORY MANAGER REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. IT IS UNKNOWN IF THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1591106 | DIALYZER | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | OGDEN MANUFACTURING PLANT | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |