Haemonetics® PCS®2 & NexSys PCS™ Systems 00620-CPRecalls & reported problems
Haemonetics Corporation · PLS Harness Set · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10812747011761), received between Jan 21, 2021 and Jun 3, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- No Apparent Adverse Event1
- Patient Device Interaction Problem1
Patient problems
- Local Reaction1
- Nasal Obstruction1
- No Clinical Signs, Symptoms or Conditions1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2021No Apparent Adverse Event; No Apparent Adverse Event
ON MAY 04, 2021 HAEMONETICS WAS NOTIFIED OF A BLAD ERROR RESULTING IN BLOOD LOSS, UTILIZING A PLASMA HARNESS SET. DURING THE PROCEDURE IT WAS REPORTED THAT EXCESSIVE BUBBLING WAS OBSERVED IN FILTER CAUSING EXCESSIVE AIR BETWEEN BOWL AND DONOR. THERE WAS ALSO A REPORT OF RED BLOOD CELL LOSS OF GREATER THAN 200ML. THE DONOR WAS DISCONNECTED IMMEDIATELY AND THERE WAS NO RECORD OF PATIENTS HEALTHS BEING IMPACTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11935125 ↗InjuryJan 21, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
ON DECEMBER 30, 2020 HAEMONETICS WAS NOTIFIED OF A DONOR REACTION THAT FIT THE DESCRIPTION OF AN ETHYLENE OXIDE REACTION WHICH OCCURRED ON THE PROCESS PHASE DURING A PROCEDURE, UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM AND PLASMA HARNESS SET. THE REACTION OCCURRED DURING SALINE INFUSION, THE DONOR EXPERIENCED PERIORBITAL SWELLING, NASAL CONGESTION AND EYE WATERING.
Patient problems: Local Reaction; Nasal Obstruction; Swelling/ Edema
MAUDE report 11207571 ↗
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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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