MCS+ 08150-110-ERecalls & reported problems
Haemonetics Corporation · MCS+ (RBC), LIST NO 08150-110-E · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30812747013875), received between Dec 30, 2020 and Sep 16, 2021 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Failure to Calibrate1
- Obstruction of Flow1
Patient problems
- Air Embolism1
- Hemolysis1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ON AUGUST 17, 2021, HAEMONETICS WAS NOTIFIED THAT OPERATOR OBSERVED A BUBBLE ENTERING DONORS ARMS AT THE VEIN PUNCTURE DURING SALINE RETURN, UTILIZING THE MCS+ SYSTEM. THE MCS+ SYSTEM DID NOT ALARM FOR AIR DETECTED.
Patient problems: Air Embolism
MAUDE report 12483000 ↗InjuryFeb 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2021, HAEMONETICS WAS NOTIFIED OF A HEMOLYSIS OCCURRED ALARM, UTILIZING THE MCS®+ 8150 SYSTEM. OPERATOR CONFIRMED HEMOLYSIS OCCURRED. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, THE PATIENTS HEALTH STATUS AND IMPACT IS UNKNOWN.
Patient problems: Hemolysis
MAUDE report 11389453 ↗MalfunctionDec 30, 2020Obstruction of Flow; Failure to Calibrate; Obstruction of Flow; Failure to Calibrate
ON DECEMBER 4, 2020 HAEMONETICS WAS NOTIFIED OF A SUSPECTED HEMOLYSIS EVENT AND A KINK IN THE TUBING UTILIZING MCS¿ 8150 SYSTEM. PATIENT STATUS IS UNKNOWN AS HAEMONETICS WAS UNABLE TO OBTAIN ADDITIONAL INFORMATION FROM CUSTOMER.
Patient problems: Insufficient Information
MAUDE report 11096031 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.