MCS+ (LN8150) RBC APHERESIS 0832F-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10812747013512), received between Mar 9, 2017 and Oct 28, 2021 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2021Mechanical Problem; Mechanical Problem

  ON (B)(6) 2021, HAEMONETICS WAS NOTIFIED OF WEIGHT CHANGING TOO SLOWLY IN RBC TRANSFER, WEIGHT CHANGING TO SLOWLY IN PLASMA RETURN, AIR DETECTED AT BLAD ALARMS DURING RETURN AND POSSIBLE RBC SPILL DURING DRAW ALARMS UTILIZING A 2 UNIT RED CELL SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12711245 ↗
• InjuryOct 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A NEEDLE STICK DUE TO A NEEDLE GUARD MALFUNCTION WHICH OCCURED POST PROCEDURE TO THE OPERATOR WHEN DISCONNECTING DONOR , UTILIZING A 2 UNIT RED CELL SET.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12595619 ↗
• InjuryJun 4, 2021Mechanical Jam; Mechanical Jam

  ON MAY 06, 2021 HAEMONETICS WAS NOTIFIED OF A NEEDLE GUARD THAT DID NOT LOCK NEEDLE AFTER DISCONNECT RESULTING IN AN ACCIDENTAL NEEDLE STICK WHICH WAS OBSERVED POST PROCEDURE, UTILIZING A 2 UNIT RED CELL SET. THE EXPOSURE STATUS OF PATIENT AND OPERATOR IS CURRENTLY UNKNOWN.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11942281 ↗
• InjuryMar 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2020, HAEMONETICS WAS INFORMED BY THE CUSTOMER THAT AFTER THE DONATION AN EMPLOYEE WAS TRYING TO REMOVE THE KIT AND THE CONNECTOR DISCONNECTED AND SPRAYED BLOOD IN THE EMPLOYEE'S EYE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9788060 ↗
• InjuryMar 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HAEMONETICS WAS NOTIFIED ON 02/09/2017 OF A NEEDLESTICK EVENT THAT OCCURRED WITH THE COLLECTION SET, (B)(4), FILTERED, UTILIZED WITH A COLLECTION ON THE MCS+ 8150 APHERESIS SYSTEM. THE USER WAS PROCESSING THE COLLECTION SET POST DONATION AND ENGAGED THE NEEDLE GUARD BY PULLING IT. THE USER THOUGHT SHE HEARD THE NEEDLE GUARD CLICK AND LOCK, BUT IT HAD NOT LOCKED AND THE USER WAS STUCK WITH THE USED NEEDLE. THE USER WAS SEEN AT A LOCAL CLINIC AND WAS GIVEN A TETANUS SHOT AS A PRECAUTIONARY MEASURE. THE USER STATED HER LAST TETANUS SHOT WAS SEVEN YEARS PRIOR TO THIS EVENT. THE USER WENT BACK TO THE CLINIC FOR A FOLLOW UP APPOINTMENT ONE WEEK LATER WITH NO HEALTH ISSUES.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6391157 ↗