CENTRISOL HEMODIALYSIS ACID CONCENTRATE
Received Apr 23, 2021 · Event occurred Apr 9, 2021
Report 2150060-2021-00006 · MDR key 11718016
Device
Generic name
Centrisol Hemodialysis Concentrate
Manufacturer
MedivatorsModel number
SB-143Lot number
489224
Product problems
- Device Ingredient or Reagent Problem
- Device Ingredient or Reagent Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE USER FACILITY REPORTED POSITIVE DETECTION OF OXIDIZING AGENTS IN THEIR DIALYSATE USING CENTRISOL ACID CONCENTRATE LOT 489224.FURTHER CUSTOMER TESTING CONFIRMED THE PRESENCE OF OXIDIZING AGENTS IN THE CENTRISOL ACID CONCENTRATE. INVESTIGATIONS PERFORMED BY MEDIVATORS ON RETURNED PRODUCTS CONFIRMED THAT A LIMITED SUBSET OF BOTTLES FROM THE IMPACTED LOT CONTAIN AN OUT-OF-SPECIFICATION CONCENTRATION FORMULATION DUE TO THE PRESENCE OF AN OXIDIZING AGENT.. A RECALL OF ALL PRODUCTS FROM THE IMPACTED LOT WILL BE CONDUCTED AND THE SITUATION WILL BE COMMUNICATED TO IMPACTED CUSTOMERS. THE USE OF OUT-OF-SPECIFICATION FORMULATIONS OF THE CONCENTRATE MAY PRESENT A RISK WHEN USED IN PATIENT PROCEDURES. HOWEVER, BOTH TEST STRIP USAGE AND CONDUCTIVITY CHECKS ARE INDICATED AS STANDARD CLINICAL PRACTICE AND WOULD MAKE THE SITUATION DETECTABLE TO THE USER. NO HARM HAS BEEN REPORTED AS A RESULT OF THIS SITUATION. MEDIVATORS HAS OPENED CAPA-(B)(4). TO ADDRESS THIS SITUATION. MEDIVATORS WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS TO ENSURE THE PRODUCT PERFORMS AS EXPECTED.
Description of Event or Problem
THE USER FACILITY REPORTED POSITIVE DETECTION OF OXIDIZING AGENTS IN THEIR DIALYSATE USING CENTRISOL ACID CONCENTRATE LOT 489224. FURTHER CUSTOMER TESTING CONFIRMED THE PRESENCE OF OXIDIZING AGENTS IN THE CENTRISOL ACID CONCENTRATE. NO HARM HAS BEEN REPORTED AS A RESULT OF THIS SITUATION.
Remedial action
- Recall