CryoMACS® Freezing Bag 500 74402Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04049934000294), received between Aug 30, 2019 and Sep 25, 2024 — classified as 24 malfunctions.

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

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024Defective Component; Defective Component

  A CUSTOMER REPORTED SEVERAL BAGS, THAT DID NOT FIT INTO THE OVERWRAP BAG. FOR ONE BAG THE CUSTOMER HAD TO REFILL THE MATERIAL INTO ANOTHER BAG. THE OTHERS WERE DETERMINED PRIOR TO USE. THE CASE IS UNDER INVESTIGATION BY THE PRODUCTION DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301058 ↗
• MalfunctionApr 18, 2024Crack; Appropriate Device Problem Term/Code Not Available; Crack; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THE BREAKAGE OF A CRYOMACS FREEZING BAG DURING THAWING. THE PATIENT WAS TREATED WITH BACKUP MATERIAL. FOR THE CRYOMACS FREEZING BAG 500 BATCH 7220600550, WITH REGARD TO THE COMPLAINT, NO DEVIATION CONCERNING THE MANUFACTURING PROCESS OCCURRED. NO ANOMALIES OCCURRED DURING THE PROCESS. THE INCIDENT RATE FOR THIS LOT WITH AND THIS TYPE OF FAILURE IS BELOW 0.01%. 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. AN OVERWRAP BAG WAS NOT USED. THE FILLING VOLUME WAS 99 ML (55 TO 100 ML ARE RECOMMENDED). THE FREEZING BAGS WERE STORED IN THE VAPOR PHASE OF LN2. ACCORDING TO THE PICTURES THE CRYOMACS FREEZING BAG IS CRACKED. THERE IS A LONG CRACK FROM THE UPPER PART OF THE BAG TO THE BOTTOM. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT IN COMBINATION WITH AN IMPROPER USER HANDLING DURING THE FREEZING PROCEDURE. NO OVERWRAP BAG WAS USED. THIS IS A DEVIATION FROM THE RECOMMENDED FREEZING PROCEDURE. THE BAG MAY HAS BEEN SLIGHTLY PINCHED IN THE METAL CASSETTE OR THE ME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19131981 ↗
• MalfunctionFeb 22, 2024Burst Container or Vessel; Appropriate Device Problem Term/Code Not Available; Burst Container or Vessel; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED TWO SHATTERED CRYOMACS 500 BAGS FOUND UPON OPENING THE CASSETTES. THE BAGS WERE OF THE SAME LOT FROZEN AT 2 INSTANCES AND STORED ON DIFFERENT SHELVES. OTHER BAGS IN THESE SHELVES WERE UNAFFECTED. THE CUSTOMER PROVIDED A FILLED IN QUESTIONAIRE, PICTURES AND ADDITIONAL INFORMATION. ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: · THE EVENTS WERE OBSERVED ON REMOVAL FROM TANK. · THE CUSTOMER DID USE A METAL CASSETTE FOR FREEZING AND FOR STORAGE. · A CONTROLLED RATE FREEZER WAS USED. · AN OVERWRAP BAG WAS NOT USED. · THE FILLING VOLUME PER BAG IS 100 ML (55 - 100 ML ARE RECOMMENDED). · THE FREEZING BAGS WERE STORED IN THE VAPOR PHASE OF LN2. ACCORDING TO THE PICTURES THE ISSUE CAN BE CONFIRMED. THE BAGS WERE SHATTERED, SEVERAL CRACKS CAN BE SEEN MOVING IN DIFFERENT DIRECTIONS OVER THE ENTIRE BAGS. FOR BOTH BAGS IT LOOKS LIKE AIR WAS ENCLOSED IN THE FROZEN MATERIAL AT THE EDGE OF THE BAG. ACCORDING TO THE ADDITIONAL INFORMATION OF THE CUSTOMER THE BAGS WERE PREPARED FOR SHIPPING AND BAGS WERE REMOVED FROM LN2 STORAGE AND KEPT INSIDE THE CASSETTES ON DRY ICE FOR ABOUT 20 MINUTES BEFORE OPENING THE CASSETTES. FOR THE CRYOMACS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18757680 ↗
• MalfunctionOct 30, 2023Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED AN INCIDENT WHERE ONE OF THE SPIKE PORTS OF A CRYOMACS FREEZING BAG 500 WAS BROKEN OFF UPON THAWING. THE CELLS WERE NOT USED FOR TRANSPLANTATION BUT BACKUP MATERIAL WAS THAWED AND USED. 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 BUT NOT FOR STORAGE. · A CONTROLLED RATE FREEZER WAS USED. · AN OVERWRAP BAG WAS USED FOR FREEZING. IT WAS NOT EVACUATED. · THE FILLING VOLUME WAS 100 ML (55 - 100 ML ARE RECOMMENDED). · THE FREEZING BAG WAS STORED IN THE LIQUID PHASE OF LN2 AND PLACED IN VAPOR PHASE PRIOR TO REMOVAL FROM TANK. ACCORDING TO THE PICTURES ONE OF THE SPIKE PORTS AT THE CRYOMACS FREEZING BAG CRACKED OFF DURING THAWING. THE QUALITY OF THE PICTURES IS NOT SUFFICIENT FOR A MORE DETAILED INVESTIGATION, BUT THE DESCRIBED ISSUE CAN BE SEEN. FOR THE CRYOMACS FREEZING BAG 500 BATCH 7230100326 NO DEVIATION CONCERNING THE MANUFACTURING PROCESS OCCURRED. NO ANOMALIES OCCURRED DURING THE PROCESS. THIS THE FIRST COMPLAINT OF THIS TYPE FOR THIS LOT WITH A INCIDENT RATE BELOW 0.1%. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18028704 ↗
• MalfunctionFeb 14, 2023Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED A CRACKED BAG AFTER SHIPMENT BETWEEN TWO FACILITIES AND DECIDED TO DISCARD THE PRODUCT AND TREAT THE PATIENT WITH BACKUP MATERIAL. A FILLED QUESTIONNAIRE AND A PICTURE WAS 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 AND FOR STORAGE. A CONTROLLED RATE FREEZER WAS USED. AN OVERWRAP BAG WAS NOT USED FOR FREEZING. THE FILLING VOLUME WAS 94 ML (55 - 100 ML ARE RECOMMENDED). THE FREEZING BAG WAS STORED IN THE VAPOR PHASE OF LN2. ADDITIONALLY IT IS DESCRIBED THAT THE CASSETTE WITH THE BAG INSIDE SLIPPED FROM A HEIGHT OF ABOUT 5 CM INTO THE SHIPPER BEFORE TRANSPORT TO ANOTHER HOSPITAL. ACCORDING TO THE PICTURES THE BAG IS CRACKED OVER THE ENTIRE BAG. IN THE STILL FROZEN PARTS, TRAPPED AIR BUBBLES AND FOAM CAN BE SEEN. THERE IS AN INDICATION THAT A LARGE AIR BUBBLE MIGHT HAVE BEEN CLOSE TO THE CENTER OF THE CRACK, HOWEVER, IT NOT POSSIBLE TO EXCLUDE THAT THE BUBBLE OCCURED AFTER THE CRACK HAD FORMED. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT DURING THE TRANSPORT IN COMBINATION WITH AN IMPROPER USER HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16370171 ↗
• MalfunctionDec 7, 2022Burst Container or Vessel; Burst Container or Vessel

  THE CUSTOMER REPORTS A CRYOMACS FREEZING BAG 500 (PRODUCT CODE 200-074-402) WHICH SHATTERED WHILE BEING THAWED AT A PATIENT'S BEDSIDE. THE BAG CONTAINED CRYOPRESERVED STEM CELLS FOR TRANSPLANT. THE BAG BEGAN TO EXPAND IMMEDIATELY UPON REMOVAL FROM LIQUID NITROGEN VAPOUR AND SHATTERED. FOR THE FREEZING BAG 500 BATCH 7211000574, NO DEVIATION CONCERNING THE MANUFACTURING PROCESS OCCURRED. NO ANOMALIES OCCURRED DURING THE PROCESS. THIS IS THE SECOND INCIDENT OF THIS TYPE FOR THIS LOT WITH A COMPLAINT RATE BELOW 0.01%. 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 AND WELDED, BUT NOT EVACUATED. · THE FILLING VOLUME WAS 98 ML (55 - 100 ML ARE RECOMMENDED). · THE FREEZING BAG WAS STORED IN THE VAPOR PHASE OF LN2. ACCORDING TO THE PICTURE THE FREEZING BAG WAS CRACKED IN THE MIDDLE ALONG THE WHOLE BAG. IT CAN BE SEEN, THAT THE OVERWRAP BAG WAS WELDED, BUT NOT EVACUATED. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT IN COMBINATION WITH A WRONG USER HAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931183 ↗
• MalfunctionAug 30, 2022Fracture; Fracture

  THE CUSTOMER REPORTED A CRACKED CRYOMACS BAG 500 AFTER THAWING WITH CONTENT LEAKING. IT WAS AN AUTOLOGOUS STEM CELL PREPARATION FROM A PATIENT. THE CUSTOMER REPORTS A CRACKED FREEZING BAG 500 (7210700504). THE BAG WAS NOT INVESTIGATED. A FILLED QUESTIONNAIRE WAS AVAILABLE. A PICTURE WAS 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. · NO OVERWRAP BAG WAS USED. · THE FILLING VOLUME WAS 100 ML (55 - 100 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 EDGE OF THE BAG. A BIG ADHESIVE LABEL WAS PUT ONTO THE FREEZING BAG. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT IN COMBINATION WITH A WRONG USER HANDLING. AN OVERWRAP BAG WAS NOT USED FOR FREEZING. THIS IS A DEVIATION FROM THE RECOMMENDED FREEZING PROCEDURE. ANOTHER DEVIATION IS THE LABELING. IT IS RECOMMENDED TO PLACE AN IDENTIFICATION TAG INTO THE LABEL POCKET OF THE FREEZING BAG. IT CANNOT BE EXCLUDED, THAT A BIG LABEL P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320024 ↗
• MalfunctionAug 1, 2022Burst Container or Vessel; Burst Container or Vessel

  THE CUSTOMER REPORTS A CRACKED FREEZING BAG 500 (7210700504). THE BAG WAS NOT INVESTIGATED, AS IT WAS DISCARDED BY THE CUSTOMER. 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 NOT USED. THIS IS RECOMMENDED. THE FILLING VOLUME WAS 96,6 ML (55 - 100 ML ARE RECOMMENDED). THE FREEZING BAG WAS STORED IN THE VAPOR PHASE OF LN2. ACCORDING TO THE PICTURES THE FREEZING BAG WAS CRACKED AT THE UPPER EDGE OF THE BAG. A BIG LABEL WAS PUT ONTO THE FREEZING BAG. ACCORDING TO THE DESCRIPTION THE CUSTOMER HEARD AN UNUSUAL LOUD CRACKING NOISE. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT IN COMBINATION WITH A WRONG USER HANDLING. AN OVERWRAP BAG WAS NOT USED FOR FREEZING. THIS IS A DEVIATION FROM THE RECOMMENDED FREEZING PROCEDURE. BREAKAGES CAN BE CAUSED BY THE PRESENCE OF AIR BUBBLES. A TYPICAL CAUSE FOR THIS PATTERN OF CRACKS AND THE FACT THAT THE CUSTOMER HEARD A LOUD CRACKING NOISE, IS THE PRESENCE OF AIR B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138998 ↗
• MalfunctionMay 12, 2022Crack; Crack

  THE CUSTOMER REPORTS A CRACKED FREEZING BAG 500 (7200600613). THE BAG WAS NOT INVESTIGATED. A FILLED QUESTIONNAIRE AND PICTURES WERE AVAILABLE. ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: THE EVENT WAS OBSERVED DURING FREEZING/STORAGE. THE CUSTOMER DID USE A METAL CASSETTE FOR FREEZING. NO STATEMENT IS MADE, IF IT WAS USED FOR STORAGE. A CONTROLLED RATE FREEZER WAS USED. AN OVERWRAP BAG WAS NOT USED. THE FILLING VOLUME WAS 100 ML (55-100 ML ARE RECOMMENDED). THE FREEZING BAG WAS STORED IN THE VAPOR PHASE OF LN2. ACCORDING TO THE PICTURES THE FREEZING BAG IS CRACKED OVER THE ENTIRE BAG. THE PICTURES SHOW, THAT THERE WAS A BIG LOOSE LABEL ATTACHED TO THE FREEZING BAG AND WAS PUT ONTO THE BAG INSIDE THE METAL CASSETTE. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT IN COMBINATION WITH A WRONG USER HANDLING. THERE ARE SEVERAL DEVIATIONS FROM THE RECOMMENDED FREEZING PROCEDURE. AN OVERWRAP BAG WAS NOT USED FOR FREEZING. ANOTHER DEVIATION IS THE LABELING. IT IS RECOMMENDED TO PLACE AN IDENTIFICATION TAG INTO THE LABEL POCKET OF THE FREEZING BAG. IT CANNOT BE EXCLUDED, THAT A LOOSE LABEL ATTACHED TO THE FREEZING BAG AND P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14375042 ↗
• MalfunctionMar 23, 2022Fracture; Fracture

  THE CUSTOMER REPORTED A CRACKED CRYOMACS FREEZING BAG 500. SIX BAGS WERE FROZEN, FOR ONE LEAKAGE WAS OBSERVED DURING THAWING. THE LEAKAGE WAS CAUSED BY A TEAR AT THE BOTTOM EDGE. THIS BAG WAS NOT TRANSPLANTED. THIS WAS WITHOUT HARM FOR THE PATIENT, AS ENOUGH MATERIAL WAS AVAILABLE. THE BAG WAS NOT INVESTIGATED. A FILLED QUESTIONNAIRE AND PICTURES WERE AVAILABLE. 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, BUT NOT FOR TRANSPORT. A CONTROLLED RATE FREEZER WAS USED. NO OVERWRAP BAG WAS USED FOR FREEZING. THE FILLING VOLUME WAS 85 ML (55-100 ML ARE RECOMMENDED). THE CRYOMACS FREEZING BAG WAS STORED IN THE LIQUID PHASE OF LN2 AND PLACED IN VAPOR PHASE PRIOR TO REMOVAL FROM THE STORAGE TANK. ACCORDING TO THE PICTURES THE CRYOMACS FREEZING BAG IS CRACKED AT ONE OF THE EDGES OF THE BAG NEAR THE LOT NUMBER. THE PICTURE SHOWS, THAT THERE IS A BIG LABEL PUT ONTO THE BAG. IT LOOKS LIKE THE CRACK IS LEADING FROM THE LABEL TOWARDS THE CORNER. AIR BUBBLES CAN BE SEEN BETWEEN THE LABEL AND THE EVA FOIL OF THE CRYOMACS FREEZING BAG. THE ISSUE IS LIKELY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869805 ↗
• MalfunctionFeb 23, 2022Crack; Crack

  DURING THE THAWING PROCESS THE CUSTOMER OBSERVED A LEAK OF THE PRODUCT IN FORM OF A PUDDLE/LEAK. THEY ASSUME IT ORIGINATED FROM A SMALL CRACK AT THE TOP OF THE BAG. THE EXACT SPOT COULD NOT BE DETERMINED. THE PATIENT DID NOT RECEIVE THE CELLS FROM THIS BAG BUT SUFFICIENT BACKUP MATERIAL WAS AVAILABLE. A REVIEW OF THE COMPLAINT DATABASE SHOWED THAT NO SIMILAR ISSUE HAS BEEN REPORTED FOR THIS LOT BEFORE. INCIDENT RATE BELOW 0.01%. INVESTIGATION BY SUBJECT MATTER EXPERT IS PENDING.

  Patient problems: Insufficient Information

  MAUDE report 13584437 ↗
• MalfunctionJul 16, 2021Crack; Crack

  THE BAGS WERE TRANSPORTED FROM MANUFACTURING SITE TO TRANSPLANT CENTER. DURING THAW IT WAS DETERMINED THAT THE BAGS WERE CRACKED. TWO BAGS WERE NOT USED FOR INFUSION FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12181276 ↗
• MalfunctionJun 25, 2021Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  CUSTOMER WAS USING A CRYOMACS FREEZING BAG 500 AND PREPARING SAMPLE FREEZE DOWN. DURING THIS PROCESS, THE CUSTOMER NOTICED A LEAK. A PART OF THE PRODUCT WAS RESCUED, SOME CELLS WERE LOST. THE CUSTOMER PROVIDED A VIDEO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12065371 ↗
• MalfunctionMar 29, 2021Crack; Crack

  THE CRYOMACS FREEZING BAG BROKE DURING REMOVAL FROM TANK. THE CUSTOMER REPORTED AIR BETWEEN CRYOMACS BAG AND OVERWRAP BAG. ENOUGH TARGET CELLS WERE LEFT FOR TREATMENT OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11582241 ↗
• MalfunctionMar 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CRYOMACS BAG WAS TORN DURING THE THAWING PROCEDURE IN THE DRY TEMPERATURE CONTROL UNIT. THE BREAKAGE WAS ON BORDER BETWEEN THE BAG AND THE REST OF THE EVA TUBING. THE PATIENT WAS TREATED WITH BACKUP MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11397453 ↗
• MalfunctionFeb 17, 2021Crack; Crack

  THE CUSTOMER REPORTS DAMAGE OF THE CRYOMACS BAG CLOSE TO ONE OF THE PORTS DURING THE THAWING PROCESS. CUSTOMER HAS THAWN 4 BAGS AND THIS ISSUE OCCURED IN ONE OF THEM. THE PATIENT RECEIVED ADDITIONAL ANTIBIOTICS.

  Patient problems: Insufficient Information

  MAUDE report 11337763 ↗
• MalfunctionFeb 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE LEAKAGE OF A BAG AFTER THAWING. THE BAG WAS FILLED WITH THE PATIENT'S TRANSPLANT MATERIAL, FROZEN ON (B)(6) 2020 AND STORED IN THE CRYOGENIC TANK. DURING DEFROSTING ON (B)(6) 2020 THE BAG UNSEALED IN THE PLACE FOR THE LABEL. THE BAG WAS DISCARDED AS ENOUGH BACKUP MATERIAL FROM OTHER BAGS WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11271964 ↗
• MalfunctionNov 25, 2020Material Puncture/Hole; Material Puncture/Hole

  WHEN UNTHAWING 6 BAGS FOR AN AUTOLOGOUS TRANSPLANTATION, A DEFECT WAS DETERMINED WITH ONE BAG. ACCORDING TO THE USER THERE WAS NO CONSEQUENCES FOR THE PATIENT, OR OTHERS. THIS IS THE FIRST REPORTED COMPLAINT CONCERNING BREAKAGE OF BAG WITH PATIENT MATERIAL LOST FOR THIS LOT. THE BAG WAS NOT INVESTIGATED. A FILLED QUESTIONNAIRE AND PICTURES WERE AVAILABLE. 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 NOT FOR STORAGE. A CONTROLLED RATE FREEZER WAS USED. THE FREEZING BAGS WERE NOT STORED WITH AN OVERWRAP BAG FOR CELL RESCUE. THE FILLING VOLUME WAS 100 ML (55 ML - 100 ML ARE RECOMMENDED). THE CELLS WERE STORED IN THE LIQUID PHASE. ACCORDING TO THE PICTURES OF THE FREEZING BAG THE BAG IS CRACKED AT THE EDGE AT THE BOTTOM OF THE BAG. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS (E.G. MECHANICAL IMPACT). ACCORDING TO THE QUESTIONNAIRE THE FREEZING BAGS WERE NOT STORED WITH AN OVERWRAP BAG AND A METAL CASSETTE. THIS IS A DEVIATION FROM THE RECOMMENDED FREEZING PROCEDURE. REGARDING TO THE DESCRIBED ISSUE, THIS SHOULD NOT HAVE AN INFLUENCE. AFTER STORAGE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10904180 ↗
• MalfunctionJul 1, 2020Material Integrity Problem; Material Integrity Problem

  MILTENYI BIOTEC WAS INFORMED ABOUT THE INCIDENT BY THE (B)(6). UNTIL NOW IT WAS NOT POSSIBLE TO OBTAIN FURTHER INFORMATION FROM THE INITIAL REPORTER, DESPITE SEVERAL ATTEMPTS. BASED ON THE PROVIDED INFORMATION: "STAMMZELLBEUTEL BEIM AUFTAUEN DEFEKT." IT CAN ONLY BE ASSUMED THAT A CRYOMACS FREEZING BAG WAS BROKEN OR LEAKED AFTER THAWING. BASED ON THE FACT THAT THE INCIDENT WAS REPORTED, IT IS LIKELY THAT THE MATERIAL WAS LOST DUE TO THE INCIDENT. IT REMAINS UNKNOWN IF OR HOW A PATIENT WAS AFFECTED. TYPICALLY BACKUP MATERIAL IS AVAILABLE FOR TREATMENT. WITH THE INFORMATION AVAILABLE NO INVESTIGATION IS POSSIBLE. COMPLAINTS FOR THE LOT HAVE BEEN REVIEWED AND THE INCIDENT RATE IS VERY LOW WITH (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10217362 ↗
• MalfunctionMay 7, 2020Burst Container or Vessel; Burst Container or Vessel

  THE CUSTOMER REPORTED A BREAKAGE DURING THAWING. DURING TAKING OUT FROM THE LIQUID NITROGEN CONTAINER, THE OVERWRAP BAG BURST, AND THE FREEZING BAG WITH THE PRODUCT INSIDE BROKE IN TWO. FOR INVESTIGATION A PICTURE AND A DESCRIPTION OF THE CUSTOMER WHERE AVAILABLE. THE CUSTOMER DID NOT PROVIDE A FILLED IN DETAILED QUESTIONNAIRE. BASED ON THIS LIMITED INFORMATION MORE THAN ONE SCENARIO IS POSSIBLE. IT SEEMS LIKELY THAT THE BAG WAS EITHER STORED IN THE LIQUID NITROGEN PHASE WITHOUT ALLOWING TRAPPED LIQUID NITROGEN TO EVAPORATE FOR AT LEAST 4H. ALTERNATIVELY, AIR MIGHT HAVE BEEN TRAPPED IN THE CRYOMACS FREEZING BAG. IT CAN ALSO NOT BE EXCLUDED THAT THE BREAKAGE OCCURRED DUE TO PHYSICAL STRESS DURING HANDLING. A REVIEW OF THE COMPLAINTS REPORTED FOR THIS LOT RESULTED IN NO OTHER SIMILAR CASES (BREAKAGE UPON THAWING).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10033084 ↗
• MalfunctionFeb 3, 2020Burst Container or Vessel; Burst Container or Vessel

  THE CUSTOMER REPORTED A BREAKAGE DURING THAWING. THE BAG WAS STORED IN LIQUID NITROGEN FOR 2 MONTHS. THE DAY BEFORE THAWING IT WAS REMOVED FROM LIQUID NITROGEN AND STORED IN VAPOR PHASE FOR 18 HOURS. ON THE DAY OF REINFUSION, THE BAG WAS TRANSFERRED TO DRY SHIPER. BEFORE THAWING THE METAL CASSETTE WAS OPENED, THE IDENTIFICATION DATA WERE CHECKED, AND THE BAG APPEARED FINE. BUT AT THE TIME WHEN IT WAS TAKEN FROM SHIPPER, AND PUT TO DRY WARMING DEVICE SAHARA THE OVERWRAP BAG EXPANDED, AND EXPLODED. WHEN THE CUSTOMER CHECKED IT, THEY FOUND THAT THE FREEZING BAG WAS DAMAGED TOO. THE PATIENT WAS TREATED WITH BACKUP MATERIAL. FOR THIS LOT MILTENYI BIOTEC RECEIVED REPORTS ABOUT FOUR BAGS AFFECTED BY BREAKAGE RELATED COMPLAINTS (HOWEVER WITH DIFFERENT FAILURES AND CAUSES). THE INCIDENT RATE IS (B)(4).THE INVESTIGATION SHOWED THAT LIKELY AIR OR LIQUID NITROGEN WAS TRAPPED INSIDE A BAG. THIS IS AVOIDED IF FOLLOWING THE VALIDATED PROTOCOL. THEREFORE A HANDLING ERROR IS ASSUMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9658735 ↗
• MalfunctionJan 28, 2020Fracture; Fracture

  THE CUSTOMER COMPLAINS A CRYOMACS FREEZING BAG 500 (6190412008) THAT BROKE UPON THAWING. PICTURES WERE AVAILABLE. A LONG CRACK OCCURED ACROSS THE SURFACE OF THE BAG. THE PATIENT RECEIVED CELLS RECOVERED FROM A STERILE OVERWRAP BAG. THE SAMPLE WAS NOT FROZEN WITH THE OVERWRAP BAG BUT PLACED INSIDE THE BAG FOR THAWING. THE PATIENT RECEIVED ANTIBIOTICS ALONG WITH THE TRANSPLANT. THE CRYOMACS FREEZING BAG PROBABLY BROKE DUE TO PHYSICAL STRESS DURING HANDLING. THE OVERWRAP BAG PROVIDED WITH THE FREEZING BAG WAS NOT USED FOR STORAGE TO STABILIZE THE BAG, THE BAG WAS SLIGHTLY OVERFILLED AND THE PROVIDED INFORMATION MAKES IT LIKELY, THAT EITHER NOT ALL AIR WAS REMOVED FROM THE BAG OR THE FLUID WAS NOT EVENLY DISTRIBUTED INSIDE THE BAG PRIOR TO FREEZING. ALL THIS IS DESCRIBED IN THE PRODUCT INFORMATION SHEET. A REVIEW OF THE COMPLAINTS REPORTED FOR THIS LOT RESULTED IN THREE SIMILAR CASES (BREAKAGE UPON THAWING). THE INCIDENT RATE IS VERY LOW WITH (B)(4)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9636102 ↗
• MalfunctionJan 15, 2020Fracture; Fracture

  THE CUSTOMER COMPLAINED ABOUT THE BREAKAGE OF A CRYOMACS FREEZING BAG DURING THAWING. PHOTOS AND AN INCOMPLETELY FILLED IN QUESTIONNAIRE WERE AVAILABLE FOR THE INVESTIGATION. THE CUSTOMER STATED THAT NO SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT OCCURED BUT DID NOT GIVE ANY DETAILS. BASED ON THE AVAILABLE INFORMATION NO DETAILED INVESTIGATION WAS POSSIBLE. A DEVIATION IN HANDLING THE BAG CAUSING PHYSICAL STRESS IS SUSPECTED. THIS IS THE SECOND COMPLAINT FOR THIS LOT WITH AN INCIDENT RATE OF (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9590670 ↗
• MalfunctionAug 30, 2019Fracture; Fracture

  THE CUSTOMER COMPLAINED A RUPTURED CRYOMACS FREEZING BAG AFTER REMOVAL FROM THE LIQUID NITROGEN TANK. NO OVERWRAP BAG WAS USED. THE PATIENT RECEIVED A BACKUP PRODUCT FOR TRANSPLANTATION. THE CUSTOMER STATED THAT THE DOSE WAS CONSIDERED TO BE SUFFICIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8950782 ↗