CryoMACS® Freezing Bag 50 74400Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04049934000270), received between Dec 13, 2019 and Nov 13, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Crack” (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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2023Crack; Appropriate Device Problem Term/Code Not Available; Crack; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED A BAG BREAKAGE AFTER THAWING. A SMALL CRACK WAS OBSERVED AT THE EDGE OF THE BAG. ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: THE EVENT WAS OBSERVED DURING THAWING. THE CUSTOMER DID USE A METAL CASSETTE FOR FREEZING BUT DID NOT PROVIDE INFORMATION IF IT WAS USED FOR STORAGE AS WELL. A CONTROLLED RATE FREEZER WAS USED. AN OVERWRAP BAG WAS NOT USED FOR FREEZING. THE FILLING VOLUME WAS 20 ML (10 - 20 ML ARE RECOMMENDED FOR CRYOMACS FREEZING BAG 50). THE FREEZING BAG WAS STORED IN THE GAS PHASE OF LN2. ACCORDING TO THE PICTURES THE CRYOMACS FREEZING BAG 50 IS CRACKED AT ONE OF THE EDGES. FOR THE CRYOMACS FREEZING BAG 50 BATCH 7220900414 WITH REGARD TO THE COMPLAINT, NO DEVIATION CONCERNING THE MANUFACTURING PROCESS OCCURRED. NO ANOMALIES OCCURRED DURING THE PROCESS. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT IN COMBINATION WITH AN IMPROPER USER HANDLING DURING THE FREEZING PROCEDURE. THE CRYOMACS FREEZING BAGS ARE VERY SENSITIVE WHEN FROZEN AND IT IS STRONGLY RECOMMENDED TO FREEZE THE CRYOMACS FREEZING BAGS ACCORDING TO THE RECOMMENDED FREEZING PROCEDURE. USING A METAL CASSETTE FOR FREEZING AS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118260 ↗
• MalfunctionSep 27, 2022Fracture; Fracture

  THE CUSTOMER REPORTS A FREEZING BAG 50 (7210700418) WITH A LEAKAGE AT THE EVA TUBE. THE EVA TUBE IS RIPPED AT THE WELDING SEAM. THE BAG WAS NOT INVESTIGATED. A FILLED QUESTIONNAIRE WAS AVAILABLE. PICTURES WERE PROVIDED. ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: · THE EVENT WAS OBSERVED DURING THAW. · THE CUSTOMER DID USE A METAL CASSETTE FOR FREEZING AND FOR STORAGE. · A CONTROLLED RATE FREEZER WAS NOT USED. · AN OVERWRAP BAG WAS USED, BUT NO STATEMENT IS MADE IF IT WAS WELDED AND EVACUATED. · THE FILLING VOLUME WAS 30 ML (10 - 20 ML ARE RECOMMENDED). · THE FREEZING BAG WAS STORED IN THE VAPOR PHASE OF LN2. ACCORDING TO THE PICTURE THE FREEZING BAG WAS CRACKED AT THE CONNECTION OF THE EVA TUBE AND THE BAG AT THE WELDING SEAM. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT IN COMBINATION WITH A WRONG USER HANDLING. THE BAG WAS OVERFILLED. THE FILLING VOLUME WAS 30 ML. THIS IS A DEVIATION AS THE RECOMMENDED FILLING VOLUME IS 10 TO 20 ML. A NEGATIVE IMPACT ON THE SAFETY OF THE PRODUCT CANNOT BE EXCLUDED AN OVERWRAP BAG WAS USED FOR FREEZING, BUT NO STATEMENT IS MADE IF IT WAS WELDED AND EVACUATED. IF NOT IT WOULD BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15494210 ↗
• MalfunctionOct 5, 2021Particulates

  PRODUCT QUALITY ISSUE- PARTICULATES OBSERVED IN CELL PRODUCT CLINICAL LOTS FROZEN IN CRYOMACS50 FREEZING BAG (INITIALLY LOT 7200400270, ALSO OBSERVED IN LOT 7200300724). WHEN THAWING AND PREPARING SUBJECT CCT6005-012'S AUTOLOGOUS GD2-CAR T CELLS FOR INFUSION, VISUAL INSPECTION SHOWED BLUE PARTICULATES. SUBSEQUENT MICROSCOPIC INSPECTION OF MULTIPLE BAGS FROM THE SAME CLINICAL MANUFACTURING RUN FOR SUBJECT CCT6005-012 ALSO DETECTED PARTICULATES OF UNKNOWN ORIGIN. INFUSION WAS CANCELED; PATIENT DID NOT RECEIVE THIS PRODUCT. GRAM STAIN, MYCOPLASMA, AND 14-DAY STERILITY RESULTS OF THE CELL PRODUCT ARE ALL NEGATIVE. A LARGER ROOT CAUSE ANALYSIS HAS DETECTED MICROSCOPIC PARTICULATES IN CRYOPRESERVED DOSES FROM THREE SEPARATE CLINICAL MANUFACTURING LOTS ALL FROZEN IN CRYOMACS 50 FREEZING BAGS FROM LOT 7200400270. AT (B)(6) SUGGESTION WE HAVE FILED AN OFFICIAL CUSTOMER COMPLAINT AND ARE WORKING WITH THEIR CONTRACTED ANALYTICAL LAB TO CHARACTERIZE THE VISIBLE AND MICROSCOPIC PARTICULATES. DURING OUR ROOT CAUSE ANALYSIS, WE HAVE ALSO FOUND MICROSCOPIC PARTICULATES IN CRYOMACS50, LOT # 7200300724. WE REPORTED THE PRODUCT QUALITY ISSUE FOR AUTOLOGOUS T-CELLS TRANSDUCED WITH RETROVIRAL VECTOR (1

  Patient problems: Insufficient Information

  MAUDE report 12583281 ↗
• MalfunctionFeb 18, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED A DETACHMENT OF A PORT AFTER REMOVAL FROM THE MICROBIOLOGICAL SAFETY CABINET. THE MATERIAL WAS DISCARDED DUE TO STERILITY CONCERNS. THE CUSTOMER STATED THAT THE PATIENT WAS NOT SERIOUSLY HARMED, LIKELY DUE TO AVAILABLE BACKUP MATERIAL. THE INVESTIGATION SHOWED THAT A LUER CONNECTION WAS LOOSE. EITHER THE CAP WAS NOT SUFFICIENTLY FASTENED DURING PRODUCTION OR IT BECAME LOOSE DUE TO TRANSPORT MOVEMENTS. THIS IS THE FIRST COMPLAINT WITH THIS FAILURE FOR THIS LOT WITH A COMPLAINT RATE BELOW (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9719713 ↗
• MalfunctionJan 31, 2020Crack; Crack

  THE REPORTER DESCRIBED THAT THE DONER TUBE BROKE DURING THAWING. WHEN A FROZEN MOBILIZED CELLULAR SAMPLE WAS THAWED AT HOSPITAL, THE STAFF OBSERVED THAT THE DONOR TUBE WAS BROKEN DOWN FROM THE END PART AND THUS THE SAMPLE COULD NOT BE USED ANY MORE. THE PATIENT WAS TREATED WITH BACKUP MATERIAL. THE BAG WAS OVERFILLED (25ML INSTEAD OF A MAXIMUM OF 20ML) AND NO OVERWRAP BAG WAS USED TO RAISE SAFETY. THIS IS THE FIRST COMPLAINT FOR THIS LOT WITH A INCIDENT RATE BELOW (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9653722 ↗
• MalfunctionDec 13, 2019Fracture; Fracture

  THE CUSTOMER FOUND UPON THAW OF FINAL PRODUCT PRIOR TO INFUSION THAT THERE WAS LEAKAGE FROM THE FINAL PRODUCT BAG INTO THE OVERWRAP BAG. UPON INVESTIGATION, A LARGE BREACH IN THE FINAL PRODUCT BAG WAS DISCOVERED. THE OVERWRAP BAG DEVELOPED A LEAK AS WELL. THIS WAS DUE TO IMPERFECTLY SEALING THE BAG, NOT AN INTEGRITY ISSUE WITH THE BAG ITSELF. THIS IS THE FIRST COMPLAINT FOR THIS LOT WITH A COMPLAINT RATE BELOW 0.01%.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9465381 ↗