DIASOL INC

Description of Event or Problem

ON 5/20/2024, A CUSTOMER REPORTED VIA EMAIL UNSTABLE CONDUCTIVITY IN DIALYSATE SOLUTION LOT NUMBER PHT12142/121423, CODE NUMBER G100225-10DEX100, RESULTING IN THE INABILITY TO DIALYZE PATIENTS. THE COMPLAINT WAS NOT DOCUMENTED, INVESTIGATED, OR EVALUATED FOR MDR REPORTABILITY AT THE TIME OF OCCURRENCE. THE COMPLAINT WAS DOCUMENTED AND INVESTIGATED AFTER AN FDA AUDIT FOUND THE ISSUE. AS A RESULT, THIS COMPLAINT IS A RETROSPECTIVE COMPLAINT. CUSTOMER QUALITY ONE RETURNED (B)(4) CASES OF PRODUCT. DURING THE INVESTIGATION, THE PRODUCT OWNER VERBALLY COMMUNICATED THAT AN INFORMAL SPECIFIC GRAVITY CHECK WAS PERFORMED ON SOME REMAINING UNITS FROM THE SAME BATCH. ACCORDING TO THE OWNER, SOME UNITS APPEARED NORMAL WHILE OTHERS APPEARED INCONSISTENT; HOWEVER, NO FORMAL TEST RECORDS OR DOCUMENTED RESULTS WERE AVAILABLE TO VERIFY THESE OBSERVATIONS. BECAUSE NO DOCUMENTED TESTING WAS PERFORMED, THESE OBSERVATIONS WERE TREATED AS ANECDOTAL INFORMATION ONLY AND NOT AS VALIDATED TEST DATA. PROBABLE CAUSE: A MALFUNCTION DURING PRODUCT TRANSFER IS SUSPECTED. A PARTIALLY OPEN WATER VALVE DURING TRANSFER FROM THE MIX TANK TO THE BOTTLING TANK COULD HAVE RESULTED IN UNINTENTIONAL DILUTION. ALTHOUGH NOT CONFIRMED, THIS FAILURE MODE IS CONSISTENT WITH THE CONDUCTIVITY DEVIATION OBSERVED IN THE RETURNED PRODUCT AND WITH A PREVIOUSLY REPORTED MDR INVOLVING THE SAME TYPE OF MALFUNCTION. RISK EVALUATION: · NO PATIENT HARM OCCURRED. · NO DOCUMENTED INTERNAL TESTING RESULTS WERE AVAILABLE FOR THE RETURNED PRODUCT. · THE CUSTOMER COMPLAINT DESCRIBES UNSTABLE CONDUCTIVITY PREVENTING TREATMENT. · THE FAILURE MODE MATCHES A PREVIOUSLY REPORTED MDR. · POTENTIAL MALFUNCTION COULD RESULT IN SERIOUS INJURY IF UNDETECTED. SEE BATCH RECORDS AND LABORATORY TEST RESULTS PERFORMED AT THE TIME OF MANUFACTURING, AS WELL AS THE DOCUMENTED TEST RESULTS GENERATED AFTER THE FIRST COMPLAINT WAS REPORTED. THESE RESULTS INCLUDE ELECTROLYTE DIALYSATE ANALYSIS. HEALTH HAZARD EVALUATION: A HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED IN ACCORDANCE WITH SOP QAPR 007 TO ASSESS PATIENT RISK ASSOCIATED WITH THE REPORTED MALFUNCTION. THE HHE DETERMINED THAT NO PATIENT HARM OCCURRED AND THAT THE MALFUNCTION MEETS THE CRITERIA FOR A REPORTABLE MALFUNCTION UNDER 21 CFR 803. THE COMPLETED HHE IS ATTACHED TO THIS COMPLAINT FILE AS SUPPORTING DOCUMENTATION. CONCLUSION: REPORTABLE MALFUNCTION. MDR DECISION: YES - REPORTABLE MALFUNCTION. JUSTIFICATION: ALTHOUGH THE PRODUCT PASSED ALL RELEASE TESTING AT THE TIME OF MANUFACTURE, THE CUSTOMER REPORTED UNSTABLE CONDUCTIVITY THAT PREVENTED TREATMENT. BECAUSE RECURRENCE OF THIS MALFUNCTION COULD RESULT IN SERIOUS INJURY IF UNDETECTED, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE MALFUNCTION UNDER 21 CFR 803. FINAL DISPOSITION: THE RETURNED PRODUCT WAS TRANSFERRED INTO DRUMS AND IS CURRENTLY HELD IN QUARANTINE. BASED ON THE INVESTIGATION AND ASSOCIATED MALFUNCTION, THE PRODUCT WILL BE SCRAPPED FOLLOWING COMPLETION OF THE COMPLAINT INVESTIGATION, MDR REPORTING, AND QA APPROVAL.