HAEMONETICS PCS 300 PLASMA COLLECTION SYSTEM PCS-300-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 30812747011659), received between Mar 9, 2020 and Aug 18, 2026 — classified as 18 deaths, 83 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (67 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 101 reports, in the reporter's own words as published by the FDA.

• DeathAug 18, 2026Adverse Event Without Identified Device or Use Problem

  The donor was a 35-year-old male qualified donor with 192 lifetime donations at the donor center dating back to (b)(6)2023. The donor presented for a routine donation on (b)(6)2026 and met all donor eligibility criteria. The donation began at 3:28 PM following a successful venipuncture in the left arm. The donor completed the full donation at 4:09 PM with a total collection volume of 956 mL and a plasma collection volume of 849 mL. The donor received 500 mL of procedural saline at the end of the procedure and 164 mL of anticoagulant was used. There were no collection exceptions or donor adverse events noted during the procedure. The donor center learned of the donor's death on (b)(6)2026 when center staff noted a social media post suggesting that the donor had died. A published online obituary confirmed that the donor died on (b)(6)2026. The obituary indicated that the donor died suddenly but no other information about the cause of death or circumstances surrounding the death was included in the obituary. Dr. (b)(6)(Director, Plasma Medical Department) contacted the (b)(6) and a representative confirmed that their office did not investigate the case. Under the Texas Code of Crimina

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308405 ↗
• DeathJun 24, 2026Adverse Event Without Identified Device or Use Problem

  THE DONOR WAS A 47-YEAR-OLD MALE QUALIFIED DONOR WITH 50 LIFETIME DONATIONS AT THE DONOR CENTER DATING BACK TO (B)(6) 2025. THE DONOR COMPLETED AN UNCOMPLICATED DONATION ON (B)(6) 2026. THERE WERE NO ISSUES IDENTIFIED WITH THE PLASMAPHERESIS DEVICE OR SOFTGOODS USED ON (B)(6) 2026. UPON REVIEW OF THE DONOR'S RECORD, DONOR ELIGIBILITY WAS DETERMINED PROPERLY, AND THE PLASMAPHERESIS PROCESS WAS PERFORMED PER THE STANDARD OPERATING PROCEDURES. THE DONOR CENTER LEARNED OF THE DONOR'S DEATH ON (B)(6) 2026 WHEN AN EMPLOYEE AT THE DONOR CENTER WHO IS A FRIEND OF THE DONOR'S SPOUSE NOTIFIED CENTER MANAGEMENT. ACCORDING TO THE INFORMATION THE DONOR'S SPOUSE PROVIDED TO THE CENTER EMPLOYEE, THE DONOR COLLAPSED AT HOME ON (B)(6) 2026 (TIME UNKNOWN) AND WAS TAKEN BY EMS TO (B)(6) WHERE HE WAS FOUND TO HAVE BRAIN SWELLING CAUSED BY A STROKE FROM BLOOD CLOTS. IN ADDITION, HE MAY HAVE ALSO HAD CORONARY ARTERY BLOOD CLOTS. HE WAS PLACED ON LIFE SUPPORT AND PASSED AWAY ON (B)(6) 2026 AT 4:28 PM. DR. (B)(6) (DIRECTOR, PLASMA MEDICAL DEPARTMENT) CONTACTED THE (B)(6) JUSTICE OF THE PEACE FOR PRECINCT #1 AND THEY CONFIRMED THAT THE DEATH WAS NOT BEING INVESTIGATED BY THEIR OFFICE. THIS IS LIKELY DUE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25609437 ↗
• DeathMar 12, 2025Adverse 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. DONOR WAS A 34-YEAR-OLD FEMALE WHO WAS NOTED TO HAVE EXPIRED DUE TO AN UNKNOWN CAUSE. DONOR HAS DONATED PLASMA SINCE (B)(6) 2022. SHE HAS DONATED 16 TIMES IN A LIFETIME AND 6 TIMES THIS YEAR. DONORS LAST DONATION WAS (B)(6) 2025. NO SIGNIFICANT INFORMATION WAS NOTED ON LAST DATE OF DONATION. REVIEW OF CHART NOTED DONOR HAD NO MEDICAL PROBLEMS EXCEPT A SMALL PAINLESS UMBILICAL HERNIA. THE DONOR WAS NOT TAKING ANY MEDICATIONS AND HAD NORMAL PHYSICAL EXAMS AND NORMAL LAB RESULTS DURING THEIR TIME DONATING. SCREENING TEST RESULTS WERE NORMAL EXCEPT DONOR HAS 2 OUT OF LIMIT HEMATOCRITS OF 35% (B)(6) 2025) AND 25% ((B)(6) 2022). REVIEW OF VITALS WERE NORMAL THROUGHOUT PLASMA DONATION. DONOR HAD 2 TEMPORARY DEFERRALS DUE TO OUT OF LIMIT HEMATOCRITS, 1 TEMPORARY DEFERRAL DUE TO BEING A LAPSED DONOR, 1 TEMPORARY MEDICAL DEFERRAL DUE TO MINOR ADVERSE EVENT LABELED AS HYPOTENSIVE/VASOVAGAL REACTION. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. THE CUSTOMER HAS NO INFORMATION FROM T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583540 ↗
• DeathJan 7, 2025Adverse 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 REPORTED AN OVER-WEIGHT 43-YEAR-OLD MALE DONOR EXPIRED SOMETIME AFTER LEAVING THE DONATION CENTER ON (B)(6) 2024 DUE TO AN UNKNOWN CAUSE. LAST DONATION OCCURRED ON (B)(6) 2024 WITH NO ISSUES REPORTED WITH THE PROCEDURE OR EQUIPMENT/DISPOSABLES USED. REVIEW OF DONOR'S CHART INDICATED NO MEDICAL PROBLEMS, NO MEDICATIONS TAKEN, NORMAL PHYSICAL EXAM, NORMAL LABS AND TEST RESULTS AND REVIEW OF VITALS WERE NORMAL. DONOR HAD NO DEFERRALS. THERE WERE NO KNOWN ALLERGIES OR PRE/POST IMMUNIZATIONS. IT IS UNKNOWN IF AN AUTOPSY WILL BE PERFORMED. THERE IS NO INFORMATION FROM THE ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR HEALTH CARE PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091589 ↗
• DeathJan 3, 2025Adverse 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 26-YEAR-OLD MALE EXPIRED ON (B)(6) 2024 FROM AN UNKNOWN CAUSE AT HIS HOME SOMETIME AFTER LEAVING A SUCCESSFUL DONATION. THE DONATION BEGAN AT 8:30 AM ON (B)(6) 2024 FOLLOWING A SUCCESSFUL VENIPUNCTURE IN THE LEFT ARM. NO APHERESIS COMPLICATIONS OR DONOR ADVERSE EVENTS WERE NOTED DURING OR AFTER THE DONATION. THE DONOR CENTER LEARNED OF THE DONOR'S DEATH ON (B)(6) 2024 WHEN THE (B)(6) MEDICAL EXAMINER'S OFFICE CONTACTED THE DONOR CENTER TO REQUEST RECORDS. NO OTHER INFORMATION WAS PROVIDED BY THE MEDICAL EXAMINER'S OFFICE. THE CUSTOMER HAS NO INFORMATION FROM THE ATTENDING PHYSICIAN, SURGEON HOSPITAL REPRESENTATIVE OR HEALTHCARE PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21071490 ↗
• DeathOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER PROVIDED THE FOLLOWING INFORMATION ON DECEMBER 4, 2024: CAUSE OF DEATH: HYPOXIC ENCEPHALOPATHY FOLLOWING RESUSCITATION FOR CARDIOPULMONARY ARREST DUE TO ATHEROSCLEROTIC AND HYPERTENSIVE HEART DISEASE. MANNER OF DEATH: NATURAL. TOXICOLOGY: NO SPECIMENS WERE SUBMITTED FOR TESTING. NO ADDITIONAL INFORMATION IS PENDING OR EXPECTED. BASED ON ALL THE AVAILABLE INFORMATION INCLUDING THE INFORMATION OUTLINED IN THE FINAL MEDICAL EXAMINER'S REPORT, THE CAUSE OF THE DEATH IS DUE TO AN UNDERLYING MEDICAL CONDITION AND NOT RELATED TO THE DONOR'S FINAL UNCOMPLICATED DONATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577535 ↗
• DeathNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, HAEMONETICS WAS MADE AWARE OF A DONOR FATALITY WHICH OCCURRED WITHIN 48 HOURS OF AN APHERESIS PROCEDURE UTILIZING THE NEXSYS PLASMA COLLECTION SYSTEM. DONOR WAS A (B)(6)-YEAR-OLD FEMALE WHO WAS NOTED TO HAVE EXPIRED ON (B)(6) 2021 DUE TO AN UNKNOWN CAUSE. SHE HAS DONATED SINCE (B)(6) 2018 AND DONATED 8-9 TIMES PER MONTH IN THE PAST SEVERAL MONTHS. DONOR'S LAST DONATION WAS (B)(6) 2021. NO SIGNIFICANT INFORMATION OR MEDICAL PROBLEMS WERE NOTED ON THE DATE OF LAST DONATION. REVIEW OF CHART NOTED A NORMAL PHYSICAL EXAM (B)(6) 2021. MOST RECENT LABS AND TEST RESULTS WERE ALSO NORMAL. DONOR'S RECORD NOTED SHE HAD A HISTORY OF ANXIETY, MOOD PROBLEMS AND HYPERTENSION FOR WHICH SHE WAS TAKING ZOLOFT, WELLBUTRIN AND METOPROLOL. REVIEW OF VITALS WERE NORMAL ON DATE OF LAST DONATION. IN THE PAST, DONOR WAS NOTED TO HAVE 2 OUT OF LIMIT PULSES ON (B)(6) 2019, 103 BPM AND (B)(6) 2019, 123 BPM. SHE WAS ALSO NOTED TO HAVE HAD 2 HYPOTENSIVE REACTIONS. THESE INCLUDED A DONOR REACTION WORKSHEET FOR HYPOTENSIVE/VASOVAGAL REACTION ON (B)(6) 2020 AND A HYPOTENSIVE/VASOVAGAL REACTION THAT REQUIRED A MEDICAL INCIDENT REPORT AND TEMPORARY DEFERRAL ON (B)(6) 2020. AFTER THE MEDICAL INCIDENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12887496 ↗
• DeathSep 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON AUGUST 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 NEXSYS PLASMA COLLECTION SYSTEM. NO SIGNIFICANT INFORMATION OR ADVERSE EVENTS WERE NOTED ON THE LAST DATE OF DONATION. REVIEW OF VITALS WERE NORMAL ON DATE OF LAST DONATION; HOWEVER, DONOR WAS NOTED TO HAVE SEVERAL DEFERRALS FOR OUT OF LIMIT DIASTOLIC BLOOD PRESSURES AND ONE DEFERRAL FOR AN OUT OF LIMIT PULSE. THE PLASMA DONATION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 800 ML OF PURE PLASMA COLLECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12483101 ↗
• DeathJul 27, 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 NEXSYS PCS SYSTEM. THE PLASMA COLLECTION PROCEDURE WAS COMPLETED SUCCESSFULLY, THERE WERE NO DIFFICULTIES NOTED DURING PROCEDURE. THE NEXSYS PCS SYSTEM COLLECTED 800ML OF PURE PLASMA AND 500ML OF SALINE INFUSED. THIS WAS THE DONORS FIRST TIME DONATING. 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 12232122 ↗
• DeathJul 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON JUNE 02, 2021, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 48 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE NEXSYS PCS SYSTEM. THE PLASMA COLLECTION PROCEDURE WAS COMPLETED SUCCESSFULLY, NO DONOR REACTIONS OR ALARMS ENCOUNTERED. THE NEXSYS PCS SYSTEM COLLECTED 799ML OF PURE PLASMA AND 500ML OF SALINE INFUSED. DONOR IS A PREVIOUS DONOR AND HAD DONATED 10 TIMES THIS YEAR. THE CAUSE OF DEATH WAS REPORTED TO BE UNKNOWN. IT IS ALSO UNKNOWN IF AN AUTOPSY WAS PERFORMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12107375 ↗
• MalfunctionMay 17, 2021Temperature Problem; Temperature Problem

  HAEMONETICS WAS NOTIFIED THAT A CUSTOMER REPORTED, "CENTRIFUGE DIST BOARD/PIECE ON BOARD BURNT/SWAPPED/FIXED". THERE WAS NO DONOR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11831892 ↗
• MalfunctionMay 17, 2021Temperature Problem; Temperature Problem

  HAEMONETICS WAS NOTIFIED THAT A CUSTOMER REPORTED THE CENTRIFUGE IS MAKING A LOUD NOISE. CUSTOMER HAS TIGHTENED THE SCREWS OF THE FUGE, THERE WAS SMOKE COMING OUT OF THE MACHINE FOR WHICH THE MACHINE WAS TAKEN OUT OF SERVICE, THERE WAS A RED AND YELLOW LIGHT. THERE WAS NO DONOR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11831635 ↗
• MalfunctionMay 12, 2021Temperature Problem; Temperature Problem

  HAEMONETICS WAS NOTIFIED THAT A CUSTOMER REPORTED CENTRIFUGE SMALL SMOKY/ SWAPPING CENTRIFUGE FIX THIS ISSUE. THERE WAS NO DONOR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812292 ↗
• MalfunctionMay 12, 2021Temperature Problem; Temperature Problem

  HAEMONETICS WAS NOTIFIED A CUSTOMER REPORTED "NEED SAFETY BOARD /DAMAGED /MELTED /BURNT / TECH THREW PART AWAY SO UNABLE TO RETURN." THERE WAS NO DONOR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812290 ↗
• MalfunctionMay 12, 2021Temperature Problem; Temperature Problem

  HAEMONETICS WAS NOTIFIED THAT A CUSTOMER REPORTED THE LINE CONDITIONER IS DAMAGED( BURNT). THERE WAS NO DONOR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812289 ↗
• MalfunctionMay 12, 2021Temperature Problem; Temperature Problem

  HAEMONETICS WAS NOTIFIED THAT A CUSTOMER REPORTED A CFG DISTT BOARD SHORTED OUT AND MELTED WHERE THE FANS CONNECT ON IT. THERE WAS NO DONOR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812286 ↗
• MalfunctionMay 12, 2021Temperature Problem; Temperature Problem

  HAEMONETICS WAS NOTIFIED THAT A CUSTOMER NEEDS A POWER ENTRY MODULE AS IT'S BURNED AND THE BUTTON FOR PINCH VALVE. THERE WAS NO DONOR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812283 ↗
• MalfunctionMay 12, 2021Temperature Problem; Temperature Problem

  HAEMONETICS WAS NOTIFIED THAT A CUSTOMER REPORTED, "NEED FRONT PANEL DISTRIBUTION CABLE, GOT CODE 23 & ALSO CHECKED THE CABLE WAS BURNT. THERE WAS NO DONOR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812282 ↗
• MalfunctionMay 12, 2021Temperature Problem; Temperature Problem

  HAEMONETICS WAS NOTIFIED THAT A CUSTOMER REPORTED "MOTOR CONTROL BOARD/SPARKED/BURNT/ FUGE POWER CABLE". THERE WAS NO DONOR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812281 ↗
• MalfunctionMay 12, 2021Temperature Problem; Temperature Problem

  HAEMONETICS WAS NOTIFIED THAT A CUSTOMER REPORTED "DUE TO OVERHEATING , THE COMPRESSOR IS DAMAGED, CX MENTIONED ITS BURNT". THERE WAS NO DONOR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812280 ↗
• MalfunctionMay 12, 2021Temperature Problem; Temperature Problem

  HAEMONETICS WAS NOTIFIED THAT A CUSTOMER REPORTED A POWER SUPPLY HAD A SMOKE SMELL TO IT AND POWER WAS NOT CALIBRATING 5VDC VOLTAGE. THERE WAS NO DONOR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812279 ↗
• MalfunctionMay 12, 2021Temperature Problem; Temperature Problem

  HAEMONETICS WAS NOTIFIED THAT A CUSTOMER REPORTED MOTOR CONTROL BOARD/BURNT. THERE WAS NO DONOR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812278 ↗
• MalfunctionMay 12, 2021Temperature Problem; Temperature Problem

  HAEMONETICS WAS NOTIFIED THAT A CUSTOMER REPORTED, "NEEDS SAFETY BOARD AS THE MACHINE KEPT ALARMING ON START UP. MOTOR CONTROL BOARD AS IT BURNT; CUFF CONNECTOR". THERE WAS NO DONOR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812277 ↗
• MalfunctionMay 12, 2021Temperature Problem; Temperature Problem

  HAEMONETICS WAS NOTIFIED THAT A CUSTOMER REPORTED "NEED MOTOR CONTROL BOARD (36823-00), AS C/F WON'T SPIN & BOARD IS ALSO BURNT. SWAPPING HELPS." THERE WAS NO DONOR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812276 ↗
• MalfunctionMay 12, 2021Temperature Problem; Temperature Problem

  HAEMONETICS WAS NOTIFIED THAT A CUSTOMER REPORTED DRIVER BOARD/ SAFETY BOARD AND CPU BOARD AS THE POWER SUPPLY BURNT THEM ALL AND ORANGE JUMPER AND AC PUMP ROTOR AND PEM AND SPLICES AND LINE SENSOR KIT AND CENTRIFUGE DIST BOARD. THERE WAS NO DONOR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812275 ↗