HAEMONETICS PCS 2 APHERESIS SYSTEM 06002-110-EXP-EWRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 30812747011970), received between Nov 8, 2017 and Nov 26, 2024 — classified as 16 deaths, 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (8 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• DeathNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MANNER OF DEATH REPORTED AS NATURAL. IMMEDIATE CAUSE OF DEATH WAS REPORTED AS DISSECTION OF THE THORACIC AORTA AND CONTRIBUTORY CAUSE OF DEATH WAS SUSPECTED HYPERTENSIVE CARDIOVASCULAR DISEASE PER HAMILTON COUNTY CORONER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788242 ↗
• DeathOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING SUBMITTED TO ALIGN WITH CUSTOMER REPORTING REQUIREMENTS. THE USE OF THE HAEMONETICS MEDICAL DEVICE IN THE DONATION PROCEDURE IS NOT SUSPECTED TO HAVE RESULTED IN THE ADVERSE OUTCOME OF THE DONOR. ON SEPTEMBER 6, 2024, CUSTOMER MADE HAEMONETICS AWARE THAT A 40-YEAR-OLD MALE DONOR PASSED AWAY ON (B)(6) 2024. THE DONOR WAS FOUND NEAR HIS HOUSE UNCONSCIOUS AND THE CAUSE OF DEATH IS A HEART ATTACK AS REPORTED BY A FAMILY MEMBER. CUSTOMER HAS NO INFORMATION FROM THE ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR HEALTH CARE PROFESSIONAL AS DEATH OCCURRED OFF-SITE FROM THE DONATION CENTER. AN AUTOPSY FROM THE MIAMI-DATE MEDICAL EXAMINER HAS NOT BEEN MADE AVAILABLE TO THE CUSTOMER. DONOR'S LAST DONATION OCCURRED ON (B)(6) 2024 AND THERE WERE NO REPORTED ISSUES WITH THE EQUIPMENT OR DISPOSABLES USED IN THE PROCEDURE AT THE TIME OF THE DONATION. THE DONOR DID NOT EXPERIENCE A REACTION OR ADVERSE EVENT DURING THE (B)(6) 2024 PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359180 ↗
• DeathSep 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 24 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS¿2 PLASMA COLLECTION SYSTEM. THE DONOR DID NOT EXPERIENCE ANY ISSUES, EVENTS OR ALARMS DURING DONATION PROCEDURE. THERE WERE NO ISSUES NOTED WITH THE DISPOSABLES DURING THE DONATION PROCEDURE. THE PLASMA DONATION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 690 ML OF PLASMA COLLECTED. DONOR HAS PREVIOUSLY DONATED WITH NO REACTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421334 ↗
• DeathJul 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY UTILIZING THE PCS¿2 PLASMA COLLECTION SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 12202090 ↗
• DeathJul 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON JUNE 03, 2021, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH OCCURRED WITHIN 24 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. ALTHOUGH DONATION WAS COMPLETED SUCCESSFULLY, DONOR DID EXPERIENCE A HIGH PRESSURE RETURN. POST DONATION DONOR HAD EXPERIENCED A MEDICAL EMERGENCY IN THE CENTERS PARKING LOT. THE DONOR WAS TRANSMITTED TO THE HOSPITAL VIA AMBULANCE WHERE THE DONOR EXPERIENCED A FULL CARDIAC ARREST AND DIED THE SAME DAY. THERE IS NO AUTOPSY REPORT AVAILABLE AT THIS TIME.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 12120062 ↗
• InjuryJun 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF TRANSIENT ISCHEMIC ATTACK SYMPTOMS WHICH WAS OBSERVED POST PROCEDURE UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. THE COLLECTION WAS COMPLETE WITH NO ERRORS OR EXCEPTIONS. POST PROCEDURE DONOR REPORTED EXPERIENCING RIGHT SIDE FACIAL NUMBNESS AND TINGLING. UPON EVALUATION CENTER STAFF MEMBER OBSERVED THAT DONOR WAS EXPERIENCING RIGHT SIDED FACIAL DROOPING AND SLURRED SPEECH. THE DONOR WAS THEN TRANSPORTED TO THE HOSPITAL VIA AMBULANCE. BASED ON EVALUATION FROM PHYSICIAN DONORS SYMPTOMS WERE NOT RELATED TO STROKE, DONOR WAS LATER DISCHARGED FROM THE HOSPITAL.

  Patient problems: Transient Ischemic Attack

  MAUDE report 12093827 ↗
• DeathJun 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON MAY 19, 2021, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 24 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS¿2 PLASMA COLLECTION SYSTEM. THE WERE NO ERRORS OBSERVED DURING DONATION. THE CAUSE OF DEATH IS UNKNOWN AND IT IS ALSO UNKNOWN IF AN AUTOPSY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12026333 ↗
• MalfunctionMay 2, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A SCREW LOOSE WHICH BURNT THE BOARD IN THE PCS®2 PLASMA COLLECTION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11758842 ↗
• InjuryFeb 5, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON JANUARY 8, 2021, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 48 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. THE PLASMA COLLECTION PROCEDURE WAS COMPLETED SUCCESSFULLY, NO DONOR REACTIONS OR ALARMS ENCOUNTERED. THE PCS®2 PLASMA COLLECTION SYSTEM COLLECTED 825ML PLASMA. THE DONOR HAD COMPLETED SEVERAL PREVIOUS DONATIONS, WITH 7 DEFERRALS DUE TO HIGH BLOOD PRESSURE. THE CENTER WAS NOTIFIED BY A RELATIVE OF THE PASSING, THE CAUSE OF DEATH WAS UNKNOWN AND AN AUTOPSY REPORT WAS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11289020 ↗
• DeathJan 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON DECEMBER 15 2020, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 24 HOURS OF THE DONOR'S LAST ATTEMPTED DONATION PROCEDURE, UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. NO PLASMA WAS COLLECTED DURING DONATION PROCEDURE AS PROCEDURE WAS STOPPED DUE TO A RBC LESS THAN ERROR CODE. THE DONOR WAS A PREVIOUS DONOR WITH ONE REPORTED REACTION OF AN UNDERDRAW. ON DAY OF DONATION DONOR WAS PROVIDED AN ELECTROLYTE DRINK AND LEFT THE CENTER IN GOOD HEALTH. HAEMONETICS WAS NOTIFIED THAT THE CAUSE OF DEATH WAS A HEART ATTACK, CAUSE OF DEATH WAS NOT CONFIRMED THROUGH AUTOPSY REPORT AS AUTOPSY REPORT WAS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11174925 ↗
• MalfunctionJan 12, 2021Overheating of Device; Overheating of Device

  ON (B)(6) 2020 HAEMONETICS WAS NOTIFIED OF A SHORT THAT OCCURS WHEN PLUGGED INTO BACK PLANE PCB ON A PCS®2 PLASMA COLLECTION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11153652 ↗
• MalfunctionDec 29, 2020Overheating of Device; Overheating of Device

  ON (B)(6) 2020 HAEMONETICS WAS NOTIFIED OF A BURNT FRONT PANEL DIST CABLE ON A PCS®2 PLASMA COLLECTION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11086957 ↗
• MalfunctionDec 21, 2020Smoking; Smoking

  ON (B)(6) 2020 HAEMONETICS WAS NOTIFIED OF SMOKE FROM THE MOTOR CONTROL BOARD ON A PCS®2 PLASMA COLLECTION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047125 ↗
• MalfunctionDec 16, 2020Overheating of Device; Overheating of Device

  ON NOVEMBER 18, 2020, HAEMONETICS WAS NOTIFIED OF AN OVERHEATING CENTRIFUGE DISTRIBUTION BOARD ON A PCS®2 PLASMA COLLECTION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11018458 ↗
• MalfunctionDec 11, 2020Increase in Pressure; Increase in Pressure

  ON (B)(6) 2020, HAEMONETICS WAS NOTIFIED OF A SUSPECTED HEMOLYSIS EVENT UTILIZING THE PCS2 PLASMA COLLECTION SYSTEM. PATIENT STATUS IS UNKNOWN AS HAEMONETICS WAS UNABLE TO OBTAIN ADDITIONAL INFORMATION FROM CUSTOMER.

  Patient problems: Hemolysis

  MAUDE report 10991230 ↗
• MalfunctionNov 30, 2020Overheating of Device; Overheating of Device

  ON NOVEMBER 04, 2020, HAEMONETICS WAS NOTIFIED OF A BURNT MOTOR CONTROL BOARD ON A PCS®2 PLASMA COLLECTION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10917843 ↗
• MalfunctionNov 20, 2020Overheating of Device; Overheating of Device

  ON (B)(6) 2020 HAEMONETICS WAS NOTIFIED OF A BURNT BACKPLANE ON A PCS®2 PLASMA COLLECTION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10874608 ↗
• MalfunctionNov 17, 2020Overheating of Device; Overheating of Device

  ON OCTOBER 23, 2020, HAEMONETICS WAS NOTIFIED OF A CENTRIFUGE NOT SPINNING ON A PCS®2 PLASMA COLLECTION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10855192 ↗
• MalfunctionNov 10, 2020Overheating of Device; Overheating of Device

  ON OCTOBER 12, 2020 HAEMONETICS WAS NOTIFIED OF A BURNT PCS®2 PLASMA COLLECTION SYSTEM MOTOR CONTROL BOARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10817259 ↗
• DeathNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OCTOBER 17 2020 HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY, WHICH HAD OCCURRED WITHIN 4 DAYS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. THE PLASMA COLLECTION PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO ERROR MESSAGES, OR ALARMS ENCOUNTERED. THERE WAS NO ADVERSE REACTION, OR INJURY EXPERIENCED DURING THE PROCEDURE. THE PCS®2 PLASMA COLLECTION SYSTEM COLLECTED 880ML OF PLASMA. THE CAUSE OF DEATH WAS UNCONFIRMED; THIS IS NOT A CORONERS' CASE, THEREFORE, CORONER REPORT WILL NOT BE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10769861 ↗
• DeathNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OCTOBER 17 2020 HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 48 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. THE PLASMA COLLECTION PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO ERROR MESSAGES OR ALARMS ENCOUNTERED. THERE WAS NO ADVERSE REACTION OR INJURY EXPERIENCED DURING THE PROCEDURE. THE PCS®2 PLASMA COLLECTION SYSTEM COLLECTED 825ML OF PLASMA. THE CAUSE OF DEATH WAS REPORTED TO BE A SUDDEN CARDIAC DEATH; HOWEVER, A COPY OF THE CORONER'S REPORT WAS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10769763 ↗
• MalfunctionOct 2, 2020Overheating of Device; Overheating of Device

  ON (B)(6) 2019 HAEMONETICS WAS NOTIFIED OF MC BOARD BURNT ON A PCS®2 PLASMA COLLECTION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10622487 ↗
• DeathSep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020 HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 24 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS2 PLASMA COLLECTION SYSTEM. THE PLASMA COLLECTION PROCEDURE WAS COMPLETED SUCCESSFULLY, COLLECTING 879ML OF PLASMA. BASED ON INFORMATION PROVIDED TO THE CUSTOMER, THE CAUSE OF DEATH WAS REPORTED TO BE OF NATURAL CAUSES, HOWEVER A COPY OF THE MEDICAL EXAMINER'S REPORT WAS NOT AVAILABLE AT THIS TIME.

  Patient problems: Death

  MAUDE report 10518925 ↗
• DeathMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 27 2019 HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 24 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. THE PLASMA COLLECTION PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO ERROR MESSAGES OR ALARMS ENCOUNTERED. THE PCS®2 PLASMA COLLECTION SYSTEM COLLECTED THE TARGET VOLUME OF 880ML OF PLASMA AND 500ML OF SALINE ADMINISTERED PER THE ROUTINE PROCEDURE. THE CAUSE OF DEATH WAS REPORTED TO BE SUDDEN CARDIAC ARREST; A COPY OF THE CORONER'S REPORT WAS AVAILABLE AT THIS TIME.

  Patient problems: Sudden Cardiac Death

  MAUDE report 9850881 ↗
• DeathMar 9, 2020No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2020, HAEMONETICS WAS INFORMED BY THE CUSTOMER OF A DONOR FATALITY FOLLOWING A SUCCESSFUL PLASMAPHERESIS PROCEDURE ON A PCS2 PLASMA COLLECTION SYSTEM. THE DONOR LEFT IN GOOD HEALTH FOLLOWING THE COMPLETION OF THE DONATION PROCEDURE. NO MEDICAL INTERVENTIONS WERE NECESSARY.

  Patient problems: Death

  MAUDE report 9806561 ↗