Haemonetics® PCS®2 & NexSys PCS™ Systems 00620-00Recalls & reported problems
Haemonetics Corporation · PLS Harness Set · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10812747011754), received between Sep 28, 2021 and Sep 28, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inadequate Filtration Process” (1 report).
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
- Inadequate Filtration Process1
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.
MalfunctionSep 28, 2021Inadequate Filtration Process; Inadequate Filtration Process
ON (B)(6), 2021 HAEMONETICS WAS NOTIFIED OF PARTICLES DETECTED IN THE DONOR TUBING WHICH OCCURRED DURING THE REMOVAL/DISASSEMBLY OF THE DISPOSABLES IN (B)(6), UTILIZING A PLASMA HARNESS SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12541127 ↗
Other Separator, automated, blood cell, diagnostic devices
- Trima Accel® 82406Terumo Bct, Inc. · Separator, automated, blood cell, diagnostic470 reports
- Trima Accel® 82446Terumo Bct, Inc. · Separator, automated, blood cell, diagnostic1 death300 reports
- Trima Accel® 81000Terumo Bct, Inc. · Separator, automated, blood cell, diagnostic150 reports
- Spectra Optia® 12220Terumo Bct, Inc. · Separator, Automated, Blood Cell, Diagnostic14 deaths147 reports
- Spectra Optia® 12320Terumo Bct, Inc. · Separator, automated, blood cell, diagnostic2 deaths119 reports
- Trima Accel® 80400Terumo Bct, Inc. · Separator, automated, blood cell, diagnostic109 reports
- Spectra Optia® 10310Terumo Bct, Inc. · Separator, automated, blood cell, diagnostic6 deaths103 reports
- HAEMONETICS PCS 300 PLASMA COLLECTION SYSTEM PCS-300-USHaemonetics Corporation · Separator, automated, blood cell, diagnostic18 deaths101 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page