Haemonetics® PCS®2, NexSys PCS™ & MCS®+ Systems 0625B-00Recalls & reported problems
Haemonetics Corporation · BMB PLS Bowls · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10812747011686), received between Feb 28, 2020 and Apr 17, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Thermal Decomposition of Device” (2 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
Device problems
- Thermal Decomposition of Device2
- Noise, Audible1
- Smoking1
Patient problems
- No Known Impact Or Consequence To Patient2
- Blood Loss1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2020Smoking; Noise, Audible; Smoking; Noise, Audible
ON (B)(6) 2020, HAEMONETICS WAS NOTIFIED OF A DEVICE MALFUNCTION THAT OCCURRED AT THE BEGINNING OF THE PROCEDURE. THE BOWL WAS REPORTED TO HAVE MADE A SCREECHING NOISE FOLLOWED BY SMOKE FROM THE CENTRIFUGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9974392 ↗MalfunctionMar 20, 2020Thermal Decomposition of Device; Thermal Decomposition of Device
ON FEBRUARY 21, 2020, HAEMONETICS WAS INFORMED BY THE CUSTOMER OF AN ADVERSE EVENT AND DEVICE MALFUNCTION DURING A PLASMAPHERESIS PROCEDURE. THERE WAS A POSSIBILITY OF THE DONOR RECEIVING HEMOLIZED RED BLOOD CELLS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9860898 ↗MalfunctionFeb 28, 2020Thermal Decomposition of Device; Thermal Decomposition of Device
ON (B)(6) 2020 - HAEMONETICS WAS INFORMED BY THE CUSTOMER OF A DEVICE MALFUNCTION THAT OCCURRED DURING A PLATELET APHERESIS PROCEDURE THAT RESULTED IN HEARING A SCREECHING NOISE AND A SMALL AMOUNT OF SMOKE WAS OBSERVED.
Patient problems: Blood Loss
MAUDE report 9771925 ↗
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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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