HAEMONETICS PCS 2 APHERESIS SYSTEM 06002-110-EXS-EWRecalls & reported problems
Haemonetics Corporation · PCS2, LN, 06002-110-EXS-EW · Class 2
All models of HAEMONETICS PCS 2 APHERESIS SYSTEM (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30812747011987), received between Nov 23, 2020 and Nov 23, 2020 — classified as 1 death.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON OCTOBER 26 2020, 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, THE PCS®2 PLASMA COLLECTION SYSTEM COLLECTED 879ML PLASMA. THE DONOR HAD COMPLETED PREVIOUS DONATIONS WITHOUT ANY ISSUES OR REACTIONS RECORDED. CUSTOMER WAS NOTIFIED BY DONORS FAMILY THAT CAUSE OF DEATH WAS A DEEP VEIN THROMBOSIS BUT AN AUTOPSY WAS NOT PERFORMED AT THIS TIME AND THERE WERE NO REPORTS AVAILABLE TO CONFIRM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10883585 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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