CryoMACS® Freezing Bag 250 74401Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04049934000287), received between Jan 8, 2020 and Jan 26, 2024 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED 5 CRACKED CRYOMACS FREEZING BAGS UPON REMOVAL FROM THE TANK. A QUESTIONAIRE AND PICTURES WERE PROVIDED. ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: · THE EVENT WAS OBSERVED ON REMOVAL FROM TANK AND DURING THAWING. · THE CUSTOMER DID USE A METAL CASSETTE FOR FREEZING AND NOT FOR STORAGE. · A CONTROLLED RATE FREEZER WAS USED. · AN OVERWRAP BAG WAS NOT USED. · NO STATEMENT IS MADE WITH REGARD TO THE FILLING VOLUME (10 - 20 ML ARE RECOMMENDED). · THE FREEZING BAG WAS STORED IN THE VAPOR PHASE OF LN2. ACCORDING TO THE PICTURES THE ISSUE CAN BE CONFIRMED. THE CRYOMACS FREEZING BAGS ARE CRACKED AT SEVERAL LOCATIONS. ONE BAG IS COMPLETELY CRACKED. THIS CAN INDICATE THAT AIR WAS ENCLOSED IN THE FROZEN MATERIAL. THE SECOND PICTURE SHOWS A SMALL CRACK AT THE EDGE OF THE BAG. THE THIRD AND THE FORTH PICTURES SHOW A CRACK OVER THE ENTIRE LENGTH OF THE BAG, BEGINNING AT THE TOP OF THE BAG NEAR THE SPIKE PORTS. THE FIFTH PICTURE SHOWS A CRACK LEADING FROM THE LOCATION OF THE ADHESIVE LABEL TO THE EDGE OF THE BAG. IT CAN BE SEEN THAT BIG ADHESIVE LABELS WERE PUT ONTO THE BAGS. FOR THE CRYOMACS FREEZING BAG 250 BATCH 7220400221, WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587149 ↗
• MalfunctionNov 13, 2023Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED A BAG BREAKAGE AFTER THAWING. ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: THE EVENTS WERE OBSERVED ON REMOVAL FROM TANK AND DURING THAWING. THE CUSTOMER DID USE A METAL CASSETTE FOR FREEZING AND THAWING. A CONTROLLED RATE FREEZER WAS USED. AN OVERWRAP BAG WAS NOT USED FOR FREEZING. THE FILLING VOLUME WAS 64 ML (30 - 70 ML ARE RECOMMENDED FOR CRYOMACS FREEZING BAG 250). THE FREEZING BAG WAS STORED IN THE GAS PHASE OF LN2. ACCORDING TO THE PICTURES THE CRYOMACS FREEZING BAG 250 IS CRACKED AT THE LOWER PART OF THE BAG. FOR THE CRYOMACS FREEZING BAG 250 BATCH 7220800467, 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. THERE ARE DEVIATIONS FROM THE RECOMMENDED FREEZING PROCEDURE. AN OVERWRAP BAG WAS NOT USED. THE PICTURE O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118326 ↗
• MalfunctionOct 11, 2023Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED A CRYOMACS FREEZING BAG 250 THAT BROKE UPON TANK REMOVAL. THE CUSTOMER PROVIDED PICTURES AND A FILLED IN QUESTIONNAIRE. ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: THE EVENT WAS OBSERVED ON REMOVAL FROM TANK; THE CUSTOMER DID NOT USE A METAL CASSETTE FOR FREEZING OR FOR STORAGE; A CONTROLLED RATE FREEZER WAS NOT USED; AN OVERWRAP BAG WAS NOT USED FOR FREEZING; THE FILLING VOLUME WAS 67 ML (30 - 70 ML ARE RECOMMENDED); THE FREEZING BAG WAS STORED IN THE LIQUID PHASE OF LN2 AND PLACED IN VAPOR PHASE PRIOR TO REMOVAL FROM STORAGE TANK. ACCORDING TO THE PICTURES THE CRYOMACS FREEZING BAG CRACKED OVER THE ENTIRE BAG. THE CRACK PATTERN INDICATES THAT IT STARTED FROM ONE SPOT AND SPREAD OVER THE ENTIRE AREA. FOR THE CRYOMACS FREEZING BAG 250 BATCH 7220400221 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. THERE ARE SEVERAL DEVIATIONS FROM THE RECOMMENDED FREEZING PROCEDURE. ACCORDING TO THE QUESTIONNAIRE NEITHER A METAL CASSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911115 ↗
• MalfunctionJul 14, 2023Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER HAD AN INSTANCE IN WHICH THEY NOTED 3 OF 4 CRYOMACS FREEZING BAGS HAD CRACKED. THE CRACKS WERE NOTED WHEN STAFF WAS RETRIEVING PRODUCTS FROM A RACK IN LN2 STORAGE. ONE BAG WAS LOST DUE TO THE INCIDENT. OTHER AFFECTED BAGS EITHER THAWED UNDER BSC AND TRANSPLANTED OR REMAINED FROZEN. FOR THE INVESTIGATION A FILLED IN QUESTIONAIRE WAS AVAILABLE. ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: · THE EVENTS WERE OBSERVED DURING THAW. · THE CUSTOMER DID USE METAL CASSETTES FOR FREEZING, BUT NO STATEMENT IS MADE IF METAL CASSETTES WERE USED FOR STORAGE. · A CONTROLLED RATE FREEZER WAS USED. · AN OVERWRAP BAG WAS NOT USED. · THE FILLING VOLUME WAS 60 ML (30 TO 70 ML ARE RECOMMENDED). · THE CRYOMACS FREEZING BAG WAS STORED IN THE VAPOR PHASE OF LN2. PICTURES WERE NOT AVAILABLE FOR INVESTIGATION. FOR THE CRYOMACS FREEZING BAG 250 BATCH 7220400221 NO DEVIATION CONCERNING THE MANUFACTURING PROCESS OCCURRED. NO ANOMALIES OCCURRED DURING THE PROCESS THE INCIDENT RATE FOR THIS LOT FOR THIS FAILURE IS BELOW 0.01% THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT IN COMBINATION WITH AN IMPROPER USER HANDLING DURING THE FREEZI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324228 ↗
• MalfunctionJun 9, 2023Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  CUSTOMER STATES THEY UTILIZE CRYOMACS BAGS FOR CELL THERAPY PRODUCT STORAGE AND INFUSION. PRODUCT WAS THAWED AT PATIENT BEDSIDE, LARGE CRACK NOTICED IN THE UPPER CORNER OF THE BAG. THE COMPLAINT RATE FOR THIS LOT IS BELOW 0.01%. FOR THE CRYOMACS FREEZING BAG 250 BATCH 7220800467, WITH REGARD TO THE COMPLAINT, NO DEVIATION CONCERNING THE MANUFACTURING PROCESS OCCURRED. NO ANOMALIES OCCURRED DURING THE PROCESS FOR INVESTIGATION A PICTURE AND A FILLED IN QUESTIONNAIRE WAS AVAILABLE. ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: · THE EVENTS WERE OBSERVED DURING THAW. · THE CUSTOMER DID USE METAL CASSETTES FOR FREEZING AND FOR STORAGE. · A CONTROLLED RATE FREEZER WAS USED. · AN OVERWRAP BAG WAS USED FOR FREEZING. NO STATEMENT IS MADE IF THE OVERWRAP BAG WAS WELDED AND EVACUATED. · THE FILLING VOLUME WAS 51 ML (30 TO 70 ML ARE RECOMMENDED). · THE CRYOMACS FREEZING BAG WAS STORED IN THE VAPOR PHASE OF LN2. ACCORDING TO THE PICTURE THE ISSUE CAN BE CONFIRMED. THE FREEZING BAG IS CRACKED AT THE EDGE OF THE BAG. IT CAN BE SEEN THAT A BIG ADHESIVE LABEL WAS PUT ONTO THE FREEZING BAG. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097613 ↗
• MalfunctionMar 29, 2023Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED A BREAKAGE UPON THAWING OF A CRYOMACS FREEZING BAG 250, LOT 7220100316. PICTURES AND A FILLED IN QUESTIONAIRE WERE PROVIDED BY THE CUSTOMER. ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: THE EVENT WERE OBSERVED DURING THAW. THE CUSTOMER DID USE METAL CASSETTES FOR FREEZING AND FOR STORAGE. A CONTROLLED RATE FREEZER WAS USED. AN OVERWRAP BAG WAS NOT USED FOR FREEZING. THE FILLING VOLUME WAS 60 ML (30 - 70 ML ARE RECOMMENDED). THE FREEZING BAG WAS STORED IN THE VAPOR PHASE OF LN2. ACCORDING TO THE PICTURES THE BAG IS CRACKED OVER THE ENTIRE BAG. THE CRACK STARTS NEAR THE SPIKE PORTS AT THE UPPER PART OF THE BAG AND LEADS TO THE MIDDLE OF THE BAG. ACCORDING TO THE PICTURES IT CAN BE SUSPECTED THAT THERE WAS A BIG AIR BUBBLE TRAPPED INSIDE THE BAG. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT IN COMBINATION WITH AN IMPROPER USER HANDLING DURING THE FREEZING PROCEDURE. ACCORDING TO THE PICTURES IT IS SUSPECTED, THAT A BIG AIR BUBBLE WAS TRAPPED INSIDE THE BAG. AIR SHOULD ABSOLUTELY BE AVOIDED IN THE SEALED FREEZING BAGS AS IT WILL EXPAND AFTER THE FREEZING PROCESS AND MAY CAUSE A BAG BREAKAGE. ACCO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16636157 ↗
• MalfunctionMar 22, 2023Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED A BAG THAT RUPTURED UPON THAWING. THE PATIENT WAS TREATED WITH BACKUP MATERIAL. FOR THE CRYOMACS FREEZING BAG 250 BATCH: 7220400221, WITH REGARD TO THE COMPLAINT, NO DEVIATION CONCERNING THE MANUFACTURING PROCESS OCCURRED. NO ANOMALIES OCCURRED DURING THE PROCESS. THE COMPLAINT RATE FOR THIS FAILURE OF THIS LOT IS BELOW (B)(4). FOR INVESTIGATION A FILLED QUESTIONNAIRE AND PICTURES WERE AVAILABLE. ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: THE EVENT WERE OBSERVED DURING THAW. THE CUSTOMER DID USE METAL CASSETTES FOR FREEZING, BUT NOT FOR STORAGE. A CONTROLLED RATE FREEZER WAS USED. AN OVERWRAP BAG WAS NOT USED FOR FREEZING. THE FILLING VOLUME WAS 65 ML (30 - 70 ML ARE RECOMMENDED). THE FREEZING BAG WAS STORED IN THE VAPOR PHASE OF LN2 AS INTENDED. ACCORDING TO THE PICTURES THE BAG CRACKED AT THE EDGE AT THE UPPER PART OF THE BAG NEAR ONE OF THE SPIKE PORTS AND THE BAG LABEL POCKET. ACCORDING TO THE CRACK PATTERN IT CANNOT BE EXCLUDED, THAT AN AIR BUBBLE WAS TRAPPED AT THE CRACKED PART OF THE BAG. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT DURING HANDLING IN COMBINATION WITH AN IMPROPER USE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589124 ↗
• MalfunctionMar 10, 2023Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER OBSERVED A LEAK WHILE INJECTING CELLS INTO A CRYOMACS BAG 250. 40 ML OF THE CELL PRODUCT WERE LOST. THE PATIENT WAS TREATED WITH BACKUP MATERIAL. THE INVESTIGATION BASED ON DESCRIPTIONS OF THE CUSTOMER SHOWED THAT THE WHITE CAP OF THE INJECTION PORT OF THE CONNECTOR SET FELL OFF. THIS WAS CAUSED BY A LOOSE LUER CONNECTION OF THE WHITE CAP OF THE INJECTION PORT AT THE CONNECTOR SET. POSSIBLE CAUSES ARE THAT THE LUER CONNECTION WAS NOT FASTENED ENOUGH DURING PRODUCTION OF THE CONNECTOR SET OR GOT LOOSE DURING PRODUCTION OF THE CRYOMACS FREEZING BAG ITSELF. ALSO TRANSPORT MOVEMENTS CAN CAUSE LOOSENING OF THE CONNECTION. IT CAN ALSO NOT BE EXCLUDED THAT IT WAS LOOSENED DURING USE AT THE CUSTOMER'S SITE. FOR THE CRYOMACS FREEZING BAG 250 BATCH 7211100355, NO DEVIATION CONCERNING THE MANUFACTURING PROCESS OCCURRED. NO ANOMALIES OCCURRED DURING THE PROCESS. THE INCIDENT RATE FOR THIS ISSUE IS BELOW 0.01%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520443 ↗
• MalfunctionOct 3, 2022Fracture; Fracture

  THE CUSTOMER REPORTS 2 CRYOMACS FREEZING BAG 250 (7210900527) WHERE THE FROZEN CELLULAR MATERIAL WAS LOST/IMPACTED BY A CRACK. THE BAGS WERE NOT INVESTIGATED. A FILLED QUESTIONNAIRE AND PICTURES WERE AVAILABLE. ACCORDING TO THE QUESTIONNAIRES THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: THE EVENTS WERE OBSERVED ON REMOVAL FROM TANK. THE CUSTOMER DID USE METAL CASSETTES FOR FREEZING AND FOR STORAGE. A CONTROLLED RATE FREEZER WAS USED. OVERWRAP BAGS WERE NOT USED FOR FREEZING. USING THE OVERWRAP BAGS IS RECOMMENDED. THE FILLING VOLUMES WERE 40 ML/ 60 ML (30-70 ML ARE RECOMMENDED). THE FREEZING BAGS WERE STORED IN THE VAPOR PHASE OF LN2. ACCORDING TO THE PICTURES AND THE QUESTIONNAIRES THE TWO CRYOMACS FREEZING BAGS WERE CRACKED ALONG THE EDGE OF THE BAG. ON ONE PICTURE IT CAN BE SEEN, THAT A BIG ADHESIVE LABEL WAS PUT ONTO THE FREEZING BAG. THE ISSUES ARE LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT IN COMBINATION WITH A WRONG USER HANDLING. OVERWRAP BAGS WERE NOT USED FOR FREEZING. THIS IS A DEVIATION FROM THE RECOMMENDED FREEZING PROCEDURE. IT IS CONCEIVABLE THAT THE BAGS HAVE BEEN SLIGHTLY PINCHED OR MOVED IN THE METAL CASSETTES RESULTING IN MECHANICAL STR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527948 ↗
• MalfunctionJul 26, 2022Fracture; Fracture

  THE CUSTOMER OBSERVED A BAG LEAK DURING THAW. THE BAG WAS REMOVED FROM CASSETTE AND PLACED IN A STERILE BAG THEN THAWED IN WATER BATH. DURING THAW, THE CELLULAR PRODUCT WAS LEAKING FROM A TEAR IN THE CORNER OF THE BAG. THIS WAS DESCRIBED AS NOT APPEARING TO BE A PUNCTURE. NEITHER BAG NOR PHOTOS WERE AVAILABLE FOR INVESTIGATION. A FILLED IN QUESTIONNAIRE WAS PROVIDED. THE LOCATION OF THE BREAKAGE WAS MARKED IN A DRAWING. CUSTOMER TESTED STERILITY AND DETERMINED NO GROWTH. 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 USED. NO OVERWRAP BAG WAS USED. THE FILLING VOLUME WAS 49 ML (30 - 70 ML ARE RECOMMENDED). THE FREEZING BAG WERE STORED IN THE VAPOR PHASE OF LN2. BASED ON THIS INFORMATION IT IS ASSUMED THAT THE FREEZING BAG WAS CRACKED AT THE EDGE. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT IN COMBINATION WITH A WRONG USER HANDLING. USING AN OVERWRAP BAG IS RECOMMENDED BUT WAS NOT USED. THIS IS A DEVIATION FROM THE RECOMMENDED FREEZING PROCEDURE. THIS INCREASES THE RISK OF SQUEEZING T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102458 ↗
• InjurySep 21, 2021Fracture; Fracture

  BREAKAGE OF A CRYOMACS FREEZING BAG. THE EVENT WAS OBSERVED ON REMOVAL FROM THE TANK. THE BAG WAS TRANSFERRED FROM THE VAPOR PHASE OF NITROGEN TO THE LIQUID PHASE AND STORE FOR ALMOST 24 HOURS. THEN IT WAS TRANSPORTED IN THE LIQUID NITROGEN CONTAINER TO ANOTHER PLACE TO TRANSFER THE BAG FROM THE LIQUID PHASE TO THE LIQUID PHASE OF ANOTHER TANK AND AFTER THAT TO A VAPOR PHASE AGAIN. DURING THIS STEP THE CRACK OF THE FREEZING BAG COULD BE HEARD. THE PATIENT WAS REMOBILISED TO GAIN FRESH CELLS DUE TO THE INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 12506870 ↗
• MalfunctionApr 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER COMPLAINS A CRACKED FREEZING BAG 250 (7200500219). THE BAG WAS NOT AVAILABLE FOR INVESTIGATION. A PICTURE AND A FILLED QUESTIONNAIRE WERE AVAILABLE. ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: THE EVENT WAS OBSERVED ON REMOVAL FROM TANK. THE CUSTOMER DID USE A METAL CASSETTE FOR FREEZING AND STORAGE. A CONTROLLED RATE FREEZER WAS USED. NO OVERWRAP BAG WAS USED. THE FILLING VOLUME WAS 70 ML (30 TO 70 ML ARE RECOMMENDED). THE FREEZING BAG WAS STORED IN THE VAPOR PHASE OF LN2. ACCORDING TO THE PICTURE IT CAN BE SEEN, THAT THE EVA TUBE IS CRACKED OFF THE FREEZING BAG. SEVERAL CRACKS AT THE EDGES OF THE BAG CAN ALSO BE SEEN. THE PICTURE SHOWS, THAT THERE IS A LARGE LABEL PUT ONTO THE FREEZING BAG.

  Patient problems: Insufficient Information

  MAUDE report 11730551 ↗
• MalfunctionMar 2, 2021Burst Container or Vessel; Burst Container or Vessel

  THE CUSTOMER REPORTED A CRYOMACS FREEZING BAG 250 (200-074-401; 7200500219) THAT BROKE DURING THAWING. THE PATIENT WAS TREATED WITH BACKUP MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11397424 ↗
• MalfunctionAug 14, 2020Crack; Crack

  THE CUSTOMER COMPLAINS TWO CRACKED FREEZING BAG 250 (7200108305). THE BAG WAS NOT AVAILABLE FOR INVESTIGATION. THE CUSTOMER SENT PICTURES FOR A MORE DETAILED INVESTIGATION WITH THE MARKED LOCATION OF THE BREAKAGE. DUE TO THE QUALITY OF THE PICTURES, THE ISSUE CANNOT BE SEEN. A FILLED IN QUESTIONNAIRE WAS AVAILABLE. THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: THE EVENT WAS OBSERVED DURING THAWING. THE CUSTOMER DID NOT USE A METAL CASSETTE FOR FREEZING BUT FOR STORAGE. A CONTROLLED RATE FREEZER WAS USED. THE FREEZING BAG WAS NOT STORED WITH AN OVERWRAP BAG AS RECOMMENDED FOR CELL RESCUE. THE FILLING VOLUME WAS 40 ML (30 - 70 ML ARE RECOMMENDED). ACCORDING TO THE QUESTIONNAIRE, THE MISSING METAL CASSETTE FOR FREEZING IS A DEVIATION FROM THE RECOMMENDED FREEZING PROCEDURE. IF THE BAG HAS BEEN PLACED IN THE METAL CASSETTE FOR STORAGE AFTER FREEZING, IT IS NOT GUARANTEED THAT THE LIQUID IS EVENLY DISTRIBUTED IN THE BAG AND IT MAY HAVE OCCURRED PRESSURE MARKS AT THE BAG. IT CANNOT BE EXCLUDED THAT THIS CONTRIBUTED TO THE BREAKAGE. THE MISSING OVERWRAP BAG IS ALSO A DEVIATION FROM THE RECOMMENDED FREEZING PROCEDURE, BUT REGARDING TO THE DESCRIBED ISSUE, THIS SHOULD NOT HAVE A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10406926 ↗
• MalfunctionJul 8, 2020Fracture; Fracture

  ON WEDNESDAY (B)(6) 2020, ONE OF OUR BMT LABORATORY TECHNOLOGIST WAS VERIFYING THE BACKUP DOSE OF CELLS (CRYOPRESERVED AUTOLOGOUS HPC, APHERSIS) IN STORAGE FOR A PATIENT WHO WILL UNDERGO A SECOND TRANSPLANT AS PART OF THEIR CANCER TREATMENT. THEIR CELLS WERE COLLECTED ON (B)(6) 2014 AND (B)(6) 2014 AND THE BACKUP CELL DOSE HAS BEEN IN STORAGE SINCE THIS TIME. UPON VISUALLY INSPECTING THE CRYO BAGS WHILE VERIFYING THE PRODUCT CELLS ARE PRESENT AND INTACT, THE BMT TECHNOLOGIST DISCOVERED A FRACTURE ON THE LEFT HAND SIDE OF ONE OF THE CRYO BAGS EXTENDING FROM THE BASE OF THE BAG TO THE TOP OF THE BAG JUST UNDER THE ACCESS PORT. THE PATIENT HAS AN ACCEPTABLE CELL DOSE TO PROCEED TO TRANSPLANT WITH THE REMAINING INTACT PRODUCT. REVIEW OF DEVIATION REPORTING DOES NOT INDICATE A TREND OF INTEGRITY FAILURES IN ASSOCIATION WITH THE AFFECTED CRYO BAG LOT AND/OR ANY OTHER LOT OF CRYO BAG. THE COMPLAINT RATE FOR THIS FAILURE WITH THIS LOT IS VERY LOW WITH (B)(4). THE CUSTOMER PROVIDED PICTURES AND A FILLED IN QUESTIONAIRE FOR INVESTIGATION. THE INVESTIGATION OF THE PICTURES SHOWS, THAT THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS DUE TO A MECHANICAL IMPACT. ACCORDING TO THE QUESTIONNAIRE THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10245275 ↗
• MalfunctionJun 30, 2020Break; Break

  DURING A THAWING PROCEDURE AT A MANUFACTURING SITE, A LEAK WAS FOUND IN THE BOTTOM LEFT SIDE OF THE BAG (RIGHT AT THE SEAM). THE BROKEN BAG WAS DISCARDED AND MANUFACTURING CONTINUED. PRODUCT WAS CRYOPRESERVED ON 4/30/2020 AT MCCT AND THAWING OCCURRED ON 5/6/2020 AT A MANUFACTURING SITE. THE CUSTOMER PROVIDED A FILED IN QUESTIONNAIRE AND A PICTURE FOR A MORE DETAILED INVESTIGATION. 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 AND FOR STORAGE. A CONTROLLED RATE FREEZER WAS USED. THE FREEZING BAG WAS NOT STORED WITH AN OVERWRAP BAG FOR CELL RESCUE. THE FILLING VOLUME WAS 49 ML (30 ML - 70 ML ARE RECOMMENDED). THE PICTURE SHOWS NO QUESTIONNAIRE AT THE BOTTOM OF THE EVA TUBE. THE ROOT CAUSE IN THIS CASE CANNOT BE DETERMINED, AS NO LEAKAGE IS VISIBLE ON THE PICTURE. THEREFORE NO REFERENCE TO THE COMPLAINT WAS POSSIBLE. ACCORDING TO THE QUESTIONNAIRE THE MISSING OVERWRAP BAG IS A DEVIATION FROM THE RECOMMENDED FREEZING PROCEDURE. REGARDING TO THE DESCRIBED ISSUE, THIS SHOULD NOT HAVE AN INFLUENCE, BUT CANNOT BE EXCLUDED. TYPICALLY, A CRACK OR LEAKAGE IS CAU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10212195 ↗
• MalfunctionMay 8, 2020Crack; Crack

  THE CLIENT INFORMED THAT DURING THE THAW PROCESS, BAG 2 WAS LEAKING FLUID FROM THE UPPER CORNER. THE BAG WITH THE LEAK WAS NOT INFUSED AND THIS PATIENT'S PRODUCT REQUIRED A SIGNIFICANT DOSE REDUCTION SO THE PATIENT WAS ABLE TO RECEIVE 2 OUT OF 3 BAGS (AROUND 92% OF TARGET TOTAL DOSE). FOR THE INVESTIGATION PHOTOS AND A FILLED IN QUESTIONNAIRE WERE AVAILABLE. THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: THE EVENT WAS OBSERVED DURING THAWING. THE CUSTOMER DID USE A METAL CASSETTE FOR FREEZING AND FOR STORAGE. A CONTROLLED RATE FREEZER WAS USED. DURING THE CRYOPRESERVATION IN THE CONTROLLED RATE FREEZER AN UNPLANNED DEVIATION OCCURRED, WHERE THE TEMPERATURE FAILED TO DROP AS EXPECTED, RESULTING IN AN ABNORMAL FREEZING PROFILE AND THE CRYOPRESERVATION WAS ABORTED. THE PRODUCT WAS TRANSFERRED INTO A NEW CONTROLLED RATE FREEZER AND THE CRYOPRESERVATION WAS REINITIATED. THE FREEZING BAG WAS NOT STORED WITH AN OVERWRAP BAG AS IT IS RECOMMENDED FOR CELL RESCUE. THE FILLING VOLUME WAS 70 ML (30 ML - 70 ML ARE RECOMMENDED). THE INVESTIGATION OF THE PICTURES CLEARLY SHOWS THAT A SMALL PIECE OF THE BAG IS BROKEN OFF. THE INVESTIGATION OF THE PICTURES SHOWS, THAT THE ISSUE IS LIKELY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10038732 ↗
• MalfunctionFeb 20, 2020Fracture; Fracture

  THE CUSTOMER REPORTED A BROKEN BAG. THE BAG WAS FROZEN USING A CONTROLLED RATE FREEZER. UPON COMPLETION OF FREEZE CYCLE, BAG WAS TRANSFERRED TO A LN2 VAPOR PHASE FREEZER. PRODUCT STORED IN A METAL CASSETTE. ON DAY 7TH, THE CASSETTE CONTAINING THE PRODUCT WAS REMOVED FROM THE VAPOR PHASE FREEZER AND TRANSFERRED IMMEDIATELY TO A BED OF DRY ICE (SMALL PELLET VARIETY). CASSETTE WAS BURIED WITHIN DRY ICE FOR APPROXIMATELY 20 MINUTES WHILE AWAITING INSPECTION. WHEN CASSETTE WAS OPENED TO PERFORM INSPECTION/VERIFICATION FOR PRODUCT TRANSFER, THE BROKEN BAG WAS DISCOVERED. FOR THE INVESTIGATION PICTURES WHERE PROVIDED. THE CUSTOMER DID NOT USE A METAL CASSETTE FOR FREEZING AND NO OVERWRAP BAG AS RECOMMENDED. AIR BUBBLES ARE VISIBLE IN THE BAG. A LIKELY REASON FOR THIS ISSUE IS, THAT NOT ALL AIR WAS REMOVED FROM THE BAG. AIR HAS TO ABSOLUTELY BE AVOIDED AS IT EXPANDS DURING THAWING AND CAN CAUSE CRACKS. THE CUSTOMER DID ALSO NOT USE AN OVERWRAP BAG AS WELL AS A METAL CASSETTE FOR THE FREEZING PROCESS AS RECOMMENDED. THIS CAN HAVE CONTRIBUTED AS WELL. THE COMPLAINT RATE FOR THIS LOT IS LOW WITH (B)(4) (INCLUDING A CASE WITH A DIFFERENT FAILURE).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9731401 ↗
• MalfunctionJan 31, 2020Material Frayed; Material Frayed

  BREAKS WERE OBSERVED UPON THAWING ON THE SIDE OF THE BAG. BREAKAGE OCCURED DURING INFUSION. THE PHYSICIAN AGREED TO CONTINUE THE INFUSION. A STERILITY TEST WAS PERFORMED AND CAME OUT NEGATIVE. THE CUSTOMER DID NOT USE AN OVERWRAP BAG TO STABILIZE THE BAG AND ENABLE RESCUE OF THE FROZEN MATERIAL. MORE RELEVANT IN THIS CASE IS THAT PROBABLY A SCISSOR CLAMP WAS USED TO HOLD THE BAG, WHAT CAUSED THE EDGES OTO BREAK. THIS IS THE SECOND COMPLAINT FOR THIS LOT WITH A INCIDENT RATE OF 0.01%.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9653700 ↗
• MalfunctionJan 8, 2020Fracture; Fracture

  THE CUSTOMER REPORTED A CRACK ON THE BAG AFTER FREEZING. THE CRACK IS ON THE MIDDLE OF THE BAG AND THE LENGTH OF THE CRACK IS LONG. THE CUSTOMER DID NOT USE AN OVERWRAP BAG TO STABILIZE THE BAG AND ENABLE RESCUE OF THE FROZEN MATERIAL. THIS IS THE FIRST COMPLAINT FOR THIS LOT WITH A INCIDENT RATE BELOW 0.01%.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9563318 ↗