AK 98 955607Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07332414124519), received between Apr 5, 2022 and Jan 7, 2025 — classified as 1 death, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 16, 2024Open, Classified

   Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

   Z-0327-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2025Filling Problem; Filling Problem

  IT WAS REPORTED THAT DURING HEMODIALYSIS THERAPY, THE AK 98 MACHINE TRIGGERED A 'HEPARIN PUMP ERROR' AND THE ENTIRE AMOUNT OF HEPARIN WAS ADMINISTERED TO THE PATIENT. TREATMENT WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093674 ↗
• MalfunctionJan 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED IN THE "ARTERIAL AND VENOUS DIALYZER CONNECTORS" OF AN AK 98 MACHINE DURING HEMODIALYSIS THERAPY. THE VOLUME OF BLOOD LOSS WAS UNKNOWN. THE BLOOD WAS NOT RETURNED TO THE PATIENT. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21061697 ↗
• MalfunctionDec 5, 2023Fluid/Blood Leak; Misconnection; Fluid/Blood Leak; Misconnection

  IT WAS REPORTED AN EXTERNAL BLOOD LEAK WAS OBSERVED ORIGINATING FROM THE VENOUS PRESSURE SENSOR OF AN AK 98 MACHINE DURING HEMODIALYSIS. UPON FURTHER INSPECTION, THE NURSE FOUND THE LUER WAS NOT CONNECTED PROPERLY CAUSING THE BLOOD TO LEAK FROM THE VENOUS PRESSURE SENSOR. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18271857 ↗
• DeathDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 10 MINUTES INTO DIALYSIS TREATMENT WITH AN AK98 MACHINE, A PATIENT WENT INTO CARDIAC ARREST AND PASSED AWAY. THE REPORTER STATED THAT, AFTER CONNECTING THE PATIENT TO THE DIALYSIS MACHINE, THE CLINICIAN HAD STEPPED AWAY ¿BRIEFLY¿ AND RETURNED TO FIND THE PATIENT HAD PASSED AWAY WITH A ¿LARGE¿ AMOUNT OF BLOOD AROUND IT. THE DEVICE WAS NOT AVAILABLE FOR ONSITE INSPECTION. DESPITE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, THE CLINIC DID NOT RESPOND.

  Patient problems: Cardiac Arrest

  MAUDE report 15978805 ↗
• MalfunctionApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER CONTACTED BAXTER REQUESTING A FUNCTIONAL CHECK ON AN AK98 CONTROL UNIT AS A PATIENT CODED WHILE PERFORMING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). MEDICAL INTERVENTION AND PATIENT OUTCOME WERE NOT REPORTED. THERE WAS NO ISSUE REPORTED WITH THE AK98 CONTROL UNIT AND THE HOSPITAL WAS ONLY FOLLOWING THEIR POLICY OF HAVING THE MACHINE CHECKED OUT BY MANUFACTURING WHEN A PATIENT INJURY IS REPORTED. DESPITE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PATIENT EVENT, PATIENT¿S DEMOGRAPHICS, MEDICAL CONDITION, OR MEDICAL HISTORY, DETAILED RELATED TO CRRT, NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Cardiac Arrest

  MAUDE report 14142831 ↗
• MalfunctionApr 5, 2022Break; Break

  IT WAS REPORTED THAT A BROKEN WHEEL WAS OBSERVED ON AN AK 98 MACHINE DURING AN UNSPECIFIED THERAPY STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015209 ↗