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CliniMACS Tubing Set LS 73205Recalls & reported problems

Miltenyi Biotec B.V. & Co. KG · CliniMACS® Tubing Set (LS) is a single-use, sterile, disposable tubing set with two proprietary cell separation columns used as part of the CliniMACS CD34 Reagent System. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while passively depleting other cells, such as CD3+ T cells, which cause graft versus host disease. The system is based on "magnetically-activated cell sorting" (MACS) employing antibodies conjugated to iron-containing particles that can be attracted to a magnetic field (referred to as “magnetic labeling”). Using the specificity of anti-CD34 antibody interaction with cell surface CD34 antigen found on hematopoietic progenitor cells, the system enriches CD34+ cells from HPC, Apheresis by passing the antibody-labeled cell suspension through a separation column with a strong magnetic gradient. The separation column retains the magnetically labeled CD34+ target cells while unlabeled cells flow through and are collected in the Negative Fraction Bag. Several automated washing steps are performed, disposing most of the liquid into the Buffer Waste Bag. The magnetically-selected CD34+ cells are released from the separation column when the magnet is disengaged, removing the magnetic field, and the target CD34+ cells are eluted into the Cell Collection Bag. · Class f

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
10
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04049934004841), received between Nov 17, 2015 and May 23, 2016 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Issue” (6 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

  • Device Issue6
  • Fluid/Blood Leak2
  • Device Operates Differently Than Expected1
  • Device Stops Intermittently1

Patient problems

  • No Information10
  • No Known Impact Or Consequence To Patient4

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 23, 2016Fluid/Blood Leak; Fluid/Blood Leak

    THE LEAKAGE OCCURRED IN A CLINIMACS TUBING SET LS AT THE Y PIECE OF TUBING ABOVE THE PRE-COLUMN. THIS EVENT HAPPENED DURING A VALIDATION RUN. THEREFORE NO PATIENT WAS AFFECTED.

    Patient problems: No Information; No Known Impact Or Consequence To Patient

    MAUDE report 5671293 ↗
  • MalfunctionMay 23, 2016Device Stops Intermittently; Device Stops Intermittently

    APPROX. 20 MIN INTO THE PROGRAM, THE INSTRUMENT DISPLAYED AN ERROR. "PUMP ERROR: PUMP DOOR OPEN" EVEN THOUGH THE OPERATOR DID NOT ADJUST THE CLINIMACS PLUS INSTRUMENT, THE PUMP DOOR WAS CLOSE AND TUBING WAS THREADED PROPERLY. THE PROGRAM GAVE THE OPERATOR APPROX. 300 SEC TO RESPONSE THE ISSUE. AFTER 300 SEC, THE RUN WAS AUTOMATICALLY ABORTED BY THE CLINIMACS PLUS INSTRUMENT. AN EMERGENCY ELUTION WAS PERFORMED. THE UNPROCESSED PRODUCT VOLUME WAS TRANSFERRED TO THE RECOVERED ELUTION AND A SECOND RUN WAS PERFORMED WITH A NEW KIT. THEREFORE, THE CELLULAR MATERIAL COULD BE RESCUED AND ANY RISK FOR THE PATIENT COULD BE RULED OUT.

    Patient problems: No Information; No Known Impact Or Consequence To Patient

    MAUDE report 5671282 ↗
  • MalfunctionMay 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

    A CLINIMACS® CD34 SELECTION HAS BEEN PERFORMED BY THE CUSTOMER. IN TOTAL 76.4XL0E9 WBC (WHITE BLOOD CELLS) INCLUDING 1.8XL0E9 CD34 CELLS HAVE BEEN PROCESSED USING ONE VIAL OF CLINIMACS® CD34 REAGENT AND THE ENRICHMENT PROGRAM SELECTION 1 APPLYING THE CLINIMACS® TUBING SET. THE CD34 YIELD AFTER THE SELECTION WAS LOW. THE CUSTOMER STATED THAT THEY USED ANOTHER TUBING SET TO SEPARATE THE CD34+ CELLS FROM THE NEGATIVE FRACTION BAG. THEREFORE ANY RISK FOR THE PATIENT COULD BE RULED OUT.

    Patient problems: No Information; No Known Impact Or Consequence To Patient

    MAUDE report 5671276 ↗
  • MalfunctionMay 19, 2016Fluid/Blood Leak; Fluid/Blood Leak

    THE LEAKAGE OCCURRED IN A CLINIMACS TUBING SET LS AT THE Y PIECE OF TUBING ABOVE THE PRE-COLUMN. THIS EVENT HAPPENED DURING A VALIDATION RUN. THEREFORE, NO PATIENT WAS AFFECTED.

    Patient problems: No Information; No Known Impact Or Consequence To Patient

    MAUDE report 5668043 ↗
  • MalfunctionMar 23, 2016Device Issue; Device Issue

    THE CUSTOMER COMPLAINED A BROKEN SPIKE OF THE DRIP CHAMBER DURING INSERTION OF THE PALL FILTER THE EVENT WAS DETECTED DURING SET UP OF THE CLINIMACS TUBING SET CE. NO RISK TO THE PATIENT.

    Patient problems: No Information

    MAUDE report 5520870 ↗
  • MalfunctionMar 4, 2016Device Issue; Device Issue

    NO SAMPLE LOADING BY CLINIMACS PLUS TUBING SET WAS COMPLAINED BY THE CUSTOMER.

    Patient problems: No Information

    MAUDE report 5480714 ↗
  • MalfunctionMar 1, 2016Device Issue; Device Issue

    CLINIMACS TUBING SET LS LEAKED AT THE JUNCTION BETWEEN THE PRIMING WASTE BAG AND TUBING. BECAUSE THIS WAS THE SECOND REPORTED CASE FOR THIS LOT THE CUSTOMER DECIDED TO QUARANTINE THE REMAINING 24 TSLS FROM THIS LOT. THE EVENT HAPPENED AT PRIMING PHASE THEREFORE MATERIAL WAS NOT AFFECTED. THE CELL SEPARATION COULD BE PERFORMED WITH A REPLACEMENT TUBING SET. THIS EVENT OCCURRED AT: (B)(6).

    Patient problems: No Information

    MAUDE report 5469994 ↗
  • MalfunctionFeb 12, 2016Device Issue; Device Issue

    CLINIMACS TUBING SET LS FAILED WHILE PROCESSING. FROM THE DESCRIPTION FROM THE CUSTOMER, IT SOUNDS LIKE AN ISSUE ON THE LINE LEADING TO THE PRIMING WASTE BAG. THE ISSUE WAS NOTICED ONCE THE SELECTION PROCESS WAS ALREADY UNDERWAY, SO THE TECH JUST CLAMPED THE LINE AND COLLECTED THE ENRICHED MATERIAL AS NORMAL AND TESTED THE CELLULAR PRODUCT FOR STERILITY PRIOR TO USAGE. THIS EVENT OCCURRED AT: (B)(6).

    Patient problems: No Information

    MAUDE report 5433966 ↗
  • MalfunctionJan 14, 2016Device Issue; Device Issue

    THE CUSTOMER REPORTED A LEAK IN THEIR CLINIMACS TUBING SET LS DURING THE PRIMING STEP. THIS EVENT OCCURRED AT: (B)(6).

    Patient problems: No Information

    MAUDE report 5367493 ↗
  • MalfunctionNov 17, 2015Device Issue

    THE CUSTOMER REPORTED THAT ONE OF THEIR CLINIMACS TUBING SETS LS WAS LEAKING NO HARM WAS CAUSED TO THE PATIENT. THE EVENT OCCURRED AT: (B)(6).

    Patient problems: No Information

    MAUDE report 5229508 ↗

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Sources and updates

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