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

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 30812747011819), received between May 21, 2020 and Nov 25, 2024 — classified as 6 deaths, 4 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• DeathNov 25, 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. CUSTOMER MADE HAEMONETICS AWARE THAT A 61-YEAR-OLD MALE DONOR PASSED AWAY ON (B)(6) 2024 FROM AN APPARENT HEART ATTACK. THE CENTER HAS NO INFORMATION FROM ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR HEALTH CARE PROFESSIONAL AS THE DONOR PASSED AWAY THE DAY AFTER THE DONATION, AT THE HOUSE OF A FRIEND. THE DONOR DID NOT EXPERIENCE A REACTION OR ADVERSE EVENT AND THERE WERE NO ERRORS ON THE MACHINE OR ISSUES REPORTED WITH THE DISPOSABLES DURING THE DONOR'S LAST DONATION ON (B)(6) 2024. THE AUTOPSY REPORT IS PENDING TOXICOLOGY RESULTS.

  Patient problems: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 20773990 ↗
• DeathNov 22, 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. CUSTOMER MADE HAEMONETICS AWARE THAT A 42-YEAR-OLD FEMALE DONOR PASSED AWAY IN HER RESIDENCE ON (B)(6) 2024 FROM A HYPERTENSIVE CARDIOVASCULAR DISEASE PER THE MEDICAL EXAMINER. AN AUTOPSY WAS NOT PERFORMED. THE CENTER HAS NO INFORMATION FROM ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR HEALTH CARE PROFESSIONAL. THE DONOR DID NOT EXPERIENCE A REACTION OR ADVERSE EVENT AND THERE WERE NO ERRORS ON THE MACHINE OR ISSUES REPORTED WITH THE DISPOSABLES DURING THE DONOR'S LAST DONATION ON (B)(6) 2024.

  Patient problems: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 20763564 ↗
• DeathSep 26, 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 4, 2024, CUSTOMER MADE HAEMONETICS AWARE THAT A 72-YEAR-OLD FEMALE DONOR PASSED AWAY ON (B)(6) 2024 FROM AN UNKNOWN CAUSE AS REPORTED BY ANOTHER DONOR. DONOR'S LAST DONATION OCCURRED ON (B)(6) 2024; SHE WAS A FIRST-TIME DONOR. DURING THE DONATION PROCESS, THE NEEDLE BECAME DISLODGED, RESULTING IN BLEEDING. THE DONOR DID NOT RECEIVE A RESTICK, HAD LESS THAN 200 ML CELL LOSS AND DID NOT EXPERIENCE A DAE. THE CENTER PROVIDED DONOR WITH ELECTROLYTE SOLUTION AND HAD DONOR WAIT 15 MINUTES. DONOR STATED THAT SHE WAS FEELING WELL PRIOR TO EXITING THE CENTER. PER DISTRICT 19 MEDICAL EXAMINERS OFFICE SERVING (B)(6), THE DEATH WAS REPORTED FROM (B)(6) HOSPITAL. CUSTOMER HAS NO INFORMATION FROM THE ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR HEALTH CARE PROFESSIONAL REGARDING THE EVENT. NO AUTOPSY OR TOXICOLOGY TESTING WAS PERFORMED BY THE MEDICAL EXAMINER SERVING (B)(6). THE MEDICAL EXAMINER'S OFFICE DEEMED THE DONOR'S DEATH "NON-ME" AND DECLINED JURISDI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20313918 ↗
• DeathJul 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 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, THERE WERE NO DIFFICULTIES NOTED DURING PROCEDURE. THE CAUSE OF DEATH IS UNKNOWN AS THE AUTOPSY RESULTS ARE PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12245628 ↗
• DeathJun 17, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON MAY 18, 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 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 12020289 ↗
• MalfunctionNov 23, 2020Overheating of Device; Overheating of Device

  ON OCTOBER 29, 2020, HAEMONETICS WAS NOTIFIED OF A BURNT PCB ON A PCS®2 PLASMA COLLECTION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10884103 ↗
• MalfunctionOct 13, 2020Overheating of Device; Overheating of Device

  ON (B)(6) 2020 HAEMONETICS WAS NOTIFIED OF A PCS®2 PLASMA COLLECTION SYSTEM DISPLAY CABLE/SIGNAL BEING BURNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10669185 ↗
• MalfunctionOct 8, 2020Overheating of Device; Overheating of Device

  ON (B)(6) 2019 HAEMONETICS WAS NOTIFIED OF A BURNT BLOOD PUMP MOTOR ON A PCS2 PLASMA COLLECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10648900 ↗
• MalfunctionOct 5, 2020Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10626619 ↗
• DeathMay 21, 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 THE DAY FOLLOWING THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. THE PLASMA COLLECTION PROCEDURE WAS COMPLETED SUCCESSFULLY, THE PCS®2 PLASMA COLLECTION SYSTEM COLLECTED 880ML OF PLASMA. THE CAUSE OF DEATH WAS UNKNOWN, AN AUTOPSY WAS PENDING AT THIS TIME.

  Patient problems: Death

  MAUDE report 10080804 ↗