ACID DIALYSATE BATH
Received Dec 20, 2023
Report 2150060-2023-00054 · MDR key 18369647
Device
Generic name
Acid Dialysate Bath
Manufacturer
Medivators IncProduct problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
UDI RELATED DATA QUALITY UPDATES ONLY -THE MODEL/CATALOG NUMBER AND LOT/SERIAL NUMBER ARE UNKNOWN; THEREFORE, THE APPLICABLE UDI AND PRODUCTION IDENTIFIERS WERE NOT INCLUDED IN THE MDR.
Description of Event or Problem
THE USER FACILITY REPORTED VIA MEDWATCH MW5147611 THAT THE DIALYSATE SOLUTION WAS UTILIZED TO TREAT THE INCORRECT PATIENT FOR APPROXIMATELY 10 MINUTES. THE INTENDED PATIENT EXPERIENCED A DELAY IN PROCEDURE. FURTHER, THE USER HAD MIXED THE DIALYSATE SOLUTION BY HAND PER THE PRESCRIBER'S ORDER, BUT THERE WAS NO VERIFICATION OF THE CORRECT VALUES.
Additional Manufacturer Narrative
THE MEDWATCH REPORT MW5147611 DID NOT PROVIDE INITIAL REPORTER INFORMATION, SERIAL NUMBER, OR USER FACILITY NAME/ADDRESS. STERIS IS NOT THE MANUFACTURER OF THE DEVICE SUBJECT OF MEDWATCH MW5147611. STERIS HAS NOTIFIED THE MANUFACTURER, EVOQUA, TO INTERNALLY INVESTIGATE AND EVALUATE FOR REPORTABILITY IN ACCORDANCE WITH 21 CFR PART 803. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.