HAEMONETICS CELL SAVER ELITE SYSTEM CSE-P-225Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10812747016544), received between Aug 16, 2017 and Sep 28, 2021 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).

6 other recalls cover devices cleared under the same FDA submission (K101907); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A LONG EMPTY ALARM WITH WASTE CONTAMINATION WHICH OCCURRED DURING A PROCEDURE IN THE UNITED KINGDOM, UTILIZING THE CELL SAVER® 5 AUTOLOGOUS RECOVERY SYSTEM AND CELL SAVER® 5 SET - 225ML. THE CELL SALVAGE BLOOD WAS REINFUSED AND APPROXIMATELY 600ML WAS DISCARDED. DONOR TRANSFUSION WAS RECEIVED.

  Patient problems: Unspecified Blood or Lymphatic problem

  MAUDE report 12541506 ↗
• MalfunctionSep 24, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A INNER CORE LEAK WHICH WAS OBSERVED DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 225ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530679 ↗
• MalfunctionJun 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ON JUNE 01, 2021 HAEMONETICS WAS NOTIFIED OF A LEAK FOUND FROM THE UPPER PART OF BOWL INTO THE CENTRIFUGE WHICH WAS OBSERVED AT 1ST CYCLE FILLING DURING A CORONARY ARTERY BYPASS PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 225ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085782 ↗
• InjuryApr 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ON MARCH 15 2021, HAEMONETICS WAS NOTIFIED OF A BLOOD LEAK OF APPROXIMATELY 400ML WHICH OCCURRED DURING A PROCEDURE IN FRANCE, UTILIZING THE CELL SAVER® 5 AUTOLOGOUS RECOVERY SYSTEM AND CELL SAVER® 5 SET - 225ML. THE BLOOD LEAK OCCURRED AT THE CONNECTION BETWEEN THE TRANSFUSION BAG AND THE TUBING. THE PROCEDURE WAS DISCONTINUED, PATIENT REFUSED BLOOD TRANSFUSION ALTHOUGH HEMOGLOBIN THRESHOLD JUSTIFIED IT. THE PATIENT EXPERIENCED LONGER CONVALESCENCE AND HOSPITALIZATION DUE TO THE INCIDENT.

  Patient problems: Unspecified Blood or Lymphatic problem

  MAUDE report 11670400 ↗
• InjuryMar 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF AN AIR DETECTED EARLY FAULT WHICH OCCURRED ON CYCLE 1 DURING A PROCEDURE IN THE (B)(6), UTILIZING THE CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM AND CELL SAVER® ELITE SET - 225ML. THE FAULT COULD NOT BE MOVED FORWARD; A SECOND MACHINE WAS THEN USED FOR THE SAME PATIENT TO CONTINUE PROCEDURE. THE SECOND CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM AND CELL SAVER® ELITE SET - 225ML DISPLAYED A LONG EMPTY FAULT ON CYCLE 1 WHICH WAS REPORTED TO BE CAUSED BY USER, BOWL NOT BEING SCANNED AND WRONG BOWL SIZE SELECTED. THERE WAS A DELAY IN THE PROCEDURE AND PATIENT HAD A 9-LITER HEMORRHAGE WHICH REQUIRED THE PATIENT TO RECEIVE A BLOOD TRANSFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11549463 ↗
• InjuryMar 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A PUMP PLATEN ISSUE DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM AND CELL SAVER® ELITE SET - 225ML. THERE WAS A DELAY IN THE PROCEDURE WHICH REQUIRED THE PATIENT TO RECEIVE A BLOOD TRANSFUSION.

  Patient problems: Unspecified Blood or Lymphatic problem

  MAUDE report 11538987 ↗
• MalfunctionJan 25, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON (B)(6) 2020 HAEMONETICS WAS NOTIFIED OF A RETURNING ERROR ALARM WHICH WAS OBSERVED DURING A PROCEDURE, UTILIZING THE CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM AND CELL SAVER® ELITE SET - 225ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11221940 ↗
• MalfunctionJul 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2020 HAEMONETICS WAS NOTIFIED OF A FLUID ERUPTION WHICH HAD OCCURRED DURING A SPINAL PROCEDURE, UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 225ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH AND NO POSSIBLE EXPOSURE TO THE TECHS INVOLVED IN CLEANING THE SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10317739 ↗
• MalfunctionApr 3, 2020Crack; Crack

  ON (B)(6) 2020, HAEMONETICS WAS NOTIFIED OF A LONG EMPTY ALARM WHICH HAD OCCURRED ON CYCLE 3 DURING A SPINAL PROCEDURE, UTILIZING THE CELL SAVER® ELITE® AUTO TRANSFUSION SYSTEM. THE DEVICE STOPPED AS A RESULT OF THE ERROR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9922638 ↗
• MalfunctionJan 29, 2020Crack; Adverse Event Without Identified Device or Use Problem; Crack; Adverse Event Without Identified Device or Use Problem

  ON 16 DECEMBER 2019: HAEMONETICS WAS INFORMED BY THE CUSTOMER OF A PATIENT DEATH THE NEXT DAY AFTER SURGERY. DURING A SURGERY WITH THE CELL SAVER ELITE PROCESSING SET EMITTED AN ALARM FOR "LIQUID IN THE CENTRIFUGE". IT WAS REPORTED THERE WAS A LOSS OF 250ML IN THE BOWL AND FROM THE BOWL RESERVOIR. THE LEAK OCCURRED ON CYCLE 4, WITH A TOTAL VOLUME REINFUSED OF 625ML DURING THE PROCEDURE.

  Patient problems: Death

  MAUDE report 9644075 ↗
• InjuryAug 16, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED (B)(6) 2017 DURING A SURGICAL PROCEDURE TO REPAIR AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT REQUIRED MULTIPLE UNITS OF RBCS DURING THE SURGERY AND POST OP DUE TO LEAKAGE OF DISPOSABLE BOWLS INTO THE WELL OF THE CELL SAVER MACHINE WHICH PROMPTED A SHUTDOWN OF THE MACHINE. THIS OCCURRED WITH THREE SEPARATE MACHINES. THE DISPOSABLES APPEARED TO HAVE A LEAK AT THE BOTTOM OF THE BOWL. AS EACH MACHINE BECAME DISABLED, ANOTHER SYSTEM WAS SET UP WITH A NEW DISPOSABLE. THE PROBLEM KEPT REPEATING UNTIL ALL MACHINES WERE NOT FUNCTIONAL AND 5 LITERS OF BLOOD COLLECTED IN A RESERVOIR THAT WAS UNABLE TO BE PROCESSED. A BELMONT RAPID INFUSER WAS USED WITH BANK BLOOD TO REPLACE THE BLOOD LOSS.

  Patient problems: Blood Loss

  MAUDE report 6797647 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101907. One submission often covers many models, so check the product and lot details in each record.

• Z-0894-2020 · Oct 21, 2019 · Terminated
  CS Elite Fastpack, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an ope
• Z-0892-2020 · Oct 21, 2019 · Terminated
  CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an opera
• Z-0895-2020 · Oct 21, 2019 · Terminated
  CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an op
• Z-0896-2020 · Oct 21, 2019 · Terminated
  CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed du
• Z-0893-2020 · Oct 21, 2019 · Terminated
  CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an opera
• Z-0779-2019 · Aug 2, 2017 · Terminated
  Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be us