CliniMACS Plus Instrument 75101Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04049934004636), received between Oct 15, 2015 and Apr 6, 2016 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device Issue” (10 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

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2016Missing Value Reason; Missing Value Reason

  THE CUSTOMER DESCRIBED POOR CD34 CELL VIABILITY (6%) AFTER A CELL SELECTION USING THE CLINIMACS CD34 CELL SELECTION SYSTEM. THE CELLS WERE NOT TRANSPLANTED. THE CUSTOMER WAS ABLE TO SEPARATE CD34+ CELLS WITHIN A SECOND SEPARATION AND TREATED THE PATIENT ACCORDINGLY. THERE WAS NO RISK TO THE PATIENT.

  Patient problems: No Information

  MAUDE report 5552181 ↗
• MalfunctionApr 1, 2016Device Difficult to Maintain; Device Difficult to Maintain

  THE CUSTOMER RECEIVED AN ERROR MESSAGE #12 ON THEIR CLINIMACS PLUS INSTRUMENT (B)(4)AFTER THE SAMPLE HAD BEEN LOADED. THE OPERATOR WAS NOT NEXT TO THE INSTRUMENT WHEN THE ERROR APPEARED, HOWEVER, THE NEGATIVE FRACTION HAD ALREADY BEEN ELUTED. NO FLUID/CELLS HAD BEEN ELUTED INTO THE POSITIVE FRACTION. ERROR 12 READS MAGNET ERROR - REFER TO MANUAL. MILTENYI TECHNICAL SERVICE WAS CALLED IMMEDIATELY AND GUIDED THE CUSTOMER THROUGH 2 EMERGENCY PROCEDURES. THEY WERE ABLE TO RESCUE CELLS, THEREFORE NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Information

  MAUDE report 5540901 ↗
• MalfunctionMar 23, 2016Device Issue; Device Issue

  THE CUSTOMER COMPLAINT THAT THEIR CLINIMACS PLUS INSTRUMENT (SN (B)(4)) ABORTED DURING CD34 RUN SELECTION 2. THE SCREEN DISPLAYED "FINAL HANDLING - PROCESS ABORTED". THIS WAS ONLY AN ENGINEERING RUN, WITHOUT PATIENT INVOLVEMENT. NO RISK TO PATIENT.

  Patient problems: No Information

  MAUDE report 5520863 ↗
• MalfunctionMar 23, 2016Device Issue; Device Issue

  THE CUSTOMER COMPLAINT THAT THEIR CLINIMACS PLUS INSTRUMENT (SN (B)(4)) SWITCHED OFF BY ITSELF. CUSTOMER HAS SEVERAL INSTRUMENTS AND THE CELL SELECTION PROCEEDED ON ANOTHER DEVICE.

  Patient problems: No Information

  MAUDE report 5520548 ↗
• MalfunctionFeb 11, 2016Device Issue; Device Issue

  THE CUSTOMER PERFORMED A LARGE SCALE CLINIMACS CD34 ENRICHMENT PROCEDURE WITH MOBILIZED APHERESIS PRODUCT CONSISTING OF 8.3X10E10 TOTAL WBCS. AFTER THE ENRICHMENT PROCESS, THE TARGET FRACTION WAS ANALYZED BY FLOW CYTOMETRY AND APPROX 38% OF THE CELLS HAD BEEN FOUND 7AAD POSITIVE, I.E. EITHER APOTOTIC OR DEAD. PROCESS CODE: 510G0O00S8O02Y0. THIS EVENT OCCURRED AT: HAMATOLOGY, ONCOLOGY & IMMUNOLOGY, BALDINGER STR. (B)(4).

  Patient problems: No Information

  MAUDE report 5431271 ↗
• MalfunctionJan 29, 2016Device Issue; Device Issue

  THE CUSTOMER COMPLAINED OF A PRE COLUMN CLOGGING DURING A CLINIMACS CD34 SEPARATION USING THE CLINIMACS PLUS INSTRUMENT. IN AN AUTOLOGOUS SETTING A LEUKAPHERESIS HARVEST CONTAINING 26X10EX10 WBC WAS GENERATED. AFTER OVERNIGHT STORAGE THE PRODUCT WAS SPLIT INTO TWO EQUAL PORTIONS AND EACH WAS LABELED AND PROCESSED SEPARATELY. ONE PORTION COULD BE PROCESSED WITHOUT ANY INCIDENT, WHEREAS THE SECOND PORTION LED TO PRE COLUMN CLOGGING. THE CUSTOMER RESCUED THE CELLS AND POOLED THEM FOR A NEW CD34 SEPARATION PROCESS USING A NEW TUBING SET. THE RE-RUN COULD BE COMPLETED WITHOUT ANY FURTHER INCIDENT AND THE RESULTS WERE EXCELLENT (98% PURITY AND 59% YIELD). CUSTOMER WAS WONDERING WHY PRE-COLUMN CLOGGING OCCURRED. THIS EVENT OCCURRED AT: (B)(6).

  Patient problems: No Information

  MAUDE report 5399151 ↗
• MalfunctionDec 17, 2015Device Issue; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER CALLED INTO THE TECHNICAL HOTLINE ON (B)(6) 2015 ADN REPORTED ON AN INCOMPLETE SAMPLE LOADING WHICH OCCURRED DURING A CLINIMACS CD34 SELECTION (ONLY 1/3 OF THE PRODUCT HAD BEEN LOADED ON THE SEPARATION COLUMN). THE FOLLOWING IMMEDIATE ACTIONS WERE TAKING BY MILTENYI BIOTEC (B)(4): EXPLAINED SITUATION: THIS INCIDENT WAS MOST LIKELY TIMED OUT DURING LOADING. THIS SCENARIO FITS TO THE OBSERVATION OF SLOW LOADING - MAYBE PARTIALLY BLOCKED PALL FILTER OR SPIKE PORT WAS THE REASON FOR THIS FINDING. THE CUSTOMER STATED THAT THE PRODUCT CONTAINED SMALL AGGREGATES. IT WAS RECOMMENDED TO LET THE PROCESS FINISH (ONLY 15 MIN TO GO) AND THEN USE A NEW CLINIMACS TUBING SET TS FOR THE REMAINING SAMPLE. THE REMAINING SAMPLE HAD TO BE FILTERED BEFORE VIA AN INLINE-FILTER AND WAS DILUTED TO 150-200 ML IN ORDER TO REDUCE THE CELL CONCENTRATION. BASED ON THE INFORMATION FROM THE CUSTOMER, RISK TO THE PATIENT CAN BE RULED OUT. THIS EVENT OCCURED AT: (B)(6).

  Patient problems: No Information

  MAUDE report 5306621 ↗
• MalfunctionNov 17, 2015Device Issue

  THE CUSTOMER REPORTED A STUCK VALVE FAILURE AT POSITION #1 ON THEIR CLINIMACS PLUS INSTRUMENT. THE CELLULAR MATERIAL WAS RESCUED AND PROCESSED USING AN ALTERNATIVE INSTRUMENT. THE CELL LOSS WAS CALCULATED TO BE 15% BUT STILL FEASIBLE FOR THERAPEUTIC USE. THERE WAS NO HARM CAUSED TO THE PATIENT. THE EVENT OCCURRED AT: (B)(6).

  Patient problems: No Information

  MAUDE report 5230475 ↗
• MalfunctionNov 17, 2015Device Maintenance Issue; Device Issue

  THE CUSTOMER CALLED TECHNICAL HOTLINE ON (B)(6) 2015 AND REPORTED AN INCOMPLETE SAMPLING LOAD DURING CLINIMACS CD34 SELECTION CLINIMACS PROCESS CODE: (B)(4). BASED ON THE INFORMATION PROVIDED NOT HARM WAS CAUSED TO PATIENT. (B)(6).

  Patient problems: No Information

  MAUDE report 5230472 ↗
• MalfunctionNov 17, 2015Device Issue

  THE CUSTOMER REPORTED THAT THEY HAD A LACERATION AT THE TOP OF THEIR CLINIMACS TUBING SET LS. THEY FIRST 3-WAY JUNCTION RIGHT BELOW THE SPIKE STARTED LEAKING BUFFER DURING THE PRIMING STEPS. THE CUSTOMER POINTED OUT THAT NO CELLULAR PRODUCT WAS INVOLVED, THEREFORE, NO PATIENT WAS HARMED. THE EVENT OCCURRED AT: (B)(6).

  Patient problems: No Information

  MAUDE report 5229524 ↗
• MalfunctionNov 17, 2015Missing Value Reason

  THE CUSTOMER REPORTED THAT AFTER PLACING THEIR CLINIMACS TUBING SET ON THEIR CLINIMACS PLUS INSTRUMENT, AND AS IT BEGAN TO PRIME, THEY NOTICED THE TUBING SET LEAKING FROM THE COLUMN. THE CELLULAR MATERIAL WAS NOT AFFECTED BECAUSE THE CELL SEPARATION WAS NOT STARTED AT THE TIME POINT OF THE EVENT, THEREFORE, NO HARM WAS CAUSED TO THE PATIENT. THE EVENT OCCURRED AT: (B)(6).

  Patient problems: No Information

  MAUDE report 5229516 ↗
• MalfunctionNov 17, 2015Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT ONE OF THEIR CLINIMACS TUBING SETS LS HAD A LEAK DURING THE UPPER INTEGRITY TEST ON THE SEPARATION COLUMN ITSELF. SPECIFICALLY FLUID WAS OBSERVED LEAKING OUT NEAR THE TOP COLUMN WHERE A VISIBLE SEAM IN THE PLASTIC IS PRESENT. A SMALL, GROWING BUBBLE WAS DISCOVERED. THE US COMPLAINTS COORDINATOR REQUESTED THE DEFECTED TUBING SET BACK FOR FURTHER INVESTIGATION. PHOTO'S WERE IMMEDIATELY AVAILABLE FOR REVIEW. THERE WAS NO HARM FOR ANY PATIENT BECAUSE THE CELL SEPARATION COULD BE PERFORMED USING A REPLACEMENT TUBING SET LS WITHOUT TIMELY DELAY. THE EVENT OCCURRED AT:(B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5229497 ↗
• MalfunctionNov 17, 2015Detachment of Device or Device Component

  THE CUSTOMER REPORTED A LEAK IN THEIR CLINIMACS TUBING SET. THEY DISCOVERED THE LEAK DURING THE BUFFER PRIMING STEP, THEREFORE, NO CELLULAR MATERIAL WAS INVOLVED AND NO PATIENT WAS HARMED. THE EVENT OCCURRED AT: (B)(6).

  Patient problems: No Information

  MAUDE report 5229494 ↗
• MalfunctionNov 13, 2015Device Maintenance Issue; Device Issue

  THE CUSTOMER HAD A PUMP ERROR ON THEIR CLINIMACS PLUS INSTRUMENT AND NOTICED RED CELLS IN THE PUMP TUBING. WHEN THEY OPENED THE CLOSED DOOR THE SYSTEM SAID THAT THE RUN WAS COMPLETE, WHICH WAS INCORRECT. THE INSTRUMENT PROCESS CODE WHICH READ; (B)(4), INDICATED A PUMP STALL ERROR. THE ENTIRE INSTRUMENT HAS TO BE TESTED BY (B)(4) TO DETERMINE WHETHER IT IS A HARDWARE RELATED ISSUE. MAINTENANCE IS PLANNED ON THE MACHINE. NO PATIENT WAS AFFECTED BY THIS INCIDENT THE EVENT OCCURRED AT: (B)(6).

  Patient problems: No Information

  MAUDE report 5222808 ↗
• MalfunctionNov 5, 2015Device Maintenance Issue; Device Issue

  THE CUSTOMER HAD A PUMP ERROR ON THEIR CLINIMACS PLUS INSTRUMENT AND NOTICED RED CELLS IN THE PUMP TUBING. WHEN THEY OPENED THE CLOSED DOOR THE SYSTEM SAID THAT THE RUN WAS COMPLETE, WHICH WAS INCORRECT. THE INSTRUMENT PROCESS CODE WHICH READ; (B)(4), INDICATED A PUMP STALL ERROR. THE ENTIRE INSTRUMENT HAS TO BE TESTED BY MILTENYI BIOTEC'S TECHNICAL SERVICE PERSONNEL TO DETERMINE WHETHERE IT IS A HARDWARE RELATED ISSUE. MAINTENANCE IS PLANNED ON THE MACHINE. NO PATIENT WAS AFFECTED BY THIS INCIDENT. THE EVENT OCCURRED AT: (B)(6).

  Patient problems: No Information

  MAUDE report 5205351 ↗
• MalfunctionOct 15, 2015No Display/Image

  THE SCREEN OF THE CLINIMACS PLUS INSTRUMENT REMAINED BLANK AFTER BEING SWITCHED ON. THE FAN OF THE INSTRUMENT TURNED CORRECTLY. THE CUSTOMER CHECKED THE INCOMING POWER SUPPLY AND THE CONNECTIONS AND THEY WERE OK. A REPAIR OF THE CLINIMACS PLUS INSTRUMENT IS ORGANIZED BY MILTENYI BIOTEC GMBH. BASED ON THE INFORMATION PROVIDED, HARM TO THE PATIENT CAN BE EXCLUDED. (B)(6)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5151051 ↗