HAEMONETICS CELL SAVER ELITE SYSTEM CSE-E-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30812747016616), received between Jan 28, 2020 and Jan 29, 2020 — classified as 2 deaths.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JANUARY 2, 2020, HAEMONETICS WAS INFORMED OF A PATIENT FATALITY VIA A MEDWATCH 3500A (003902226-2019-0001) SENT IN THE MAIL. SURGERY PROGRESSED NORMALLY. EST. BLOOD LOSS 300ML. AT CONCLUSION WHEN CLOSING SKIN AND RETURNING BLOOD TO PATIENT THE PATIENT WENT INTO CARDIAC ARREST. PATIENT EXPIRED DESPITE RESUSCITATION EFFORTS.

  Patient problems: Sudden Cardiac Death

  MAUDE report 9643651 ↗
• DeathJan 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 12-DECEMBER-2019 HAEMONETICS WAS INFORMED OF A PATIENT FATALITY WHICH OCCURRED ON (B)(6) 2017 USING A CELL SAVER ELITE MACHINE. THE PATIENT FATALITY OCCURED POST-OPERATION PROCEDURE FOR REMOVAL OF FIBROIDS. NEAR THE END OF THE PROCEDURE ANESTHESIA STATED THAT THE PATIENT WAS HAVING SOME HEMODYNAMIC INSTABILITY AND THE INSTABILITY OCCURRED SHORTLY AFTER THE INFUSION OF CELL SAVER WASHED PRODUCT. PATIENT RECEIVED APPROX. 300 ML OF 400 ML AVAILABLE FOR REINFUSION OF WASHED CELLS. THE PATIENT EXPIRED LATER THAT NIGHT/EARLY MORNING.

  Patient problems: Death

  MAUDE report 9638155 ↗