TSCD® II 3MESC203ARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05020583300033), received between Dec 21, 2018 and Nov 26, 2019 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionNov 26, 2019Use of Device Problem; Break; Unintended Ejection; Use of Device Problem; Activation, Positioning or Separation Problem

  THE CUSTOMER REPORTED THAT WHILE USING THE TSCDII WELDER TO PROCESS PACKED CELL PRODUCTS THE WELDER WAS NOT EJECTING THE WAFER AFTER SEALING WAS COMPLETE. PER THE CUSTOMER, THE OPERATOR PERFORMED 9 WELDS BEFORE THEY NOTICED THE WELDS HAD A STRINGY MATERIAL WHEN REMOVED FROM THE WELDER JAWS. AT THIS TIME, THE OPERATOR NOTICED THE WAFER DID NOT EJECT, AND IT WAS REPORTED WAS STATED THE WAFER LOOKED "DAMAGED". THE CUSTOMER EXPRESSED CONCERN FOR THE STERILITY OF THE PRODUCTS. PER THE CUSTOMER, THE FIRST WELD LEAK WAS NOTICED ON (B)(6) 2019, THE 2ND WELD LEAK WAS FOUND ON (B)(6) 2019 AND THE DEVICE WAS TAKEN OUT OF SERVICE THE SAME DAY. IT IS UNKNOWN AT THIS TIME WHAT THE DISPOSITION OF THE PRODUCTS WAS OR IF THEY WERE USED ON A PATIENT, PER THE CUSTOMER, NO TESTING WAS PERFORMED ON THE UNITS. THE CUSTOMER DECLINED TO PROVIDE PATIENT INFORMATION OR OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9377004 ↗
• MalfunctionNov 26, 2019Use of Device Problem; Break; Leak/Splash; Use of Device Problem; Structural Problem; Appropriate Device Problem Term/Code Not Available

  DURING FOLLOW-UP WITH THE CUSTOMER IT WAS REPORTED THAT WHEN THE CUSTOMER FIRST NOTICED THAT THE WAFER DID NOT ADVANCE, THEY CHECKED THEIR LOG AND FOUND 2 RECENT WELD FAILURES DOCUMENTED. FROM THE FIRST TO THE LAST, THERE WERE A TOTAL OF 9 WELDS A TOTAL OF 6 DONOR UNITS. EACH WELD RESULTED IN AN ORIGINAL PRODUCT AND THE NEW ALIQUOT, SO EACH AFFECTED WELD POTENTIALLY AFFECTS 2-3 PARTIAL UNITS. IT WAS REPORTED THAT IF THE REMAINDER OF THE ORIGINAL BAG WAS STILL IN THE REFRIGERATOR AT THE CUSTOMER SITE, IT WAS DISCARDED. IF EITHER THE ORIGINAL BAG OR THE ALIQUOT HAD BEEN TRANSFUSED TO A PATIENT, IT WAS NOTED, AND THESE WERE THE ONES REPORTED TO FDA. THE CUSTOMER REPORTED 8 ALIQUOTS ON 6 DIFFERENT UNITS OF BLOOD (2 UNITS HAD 2 ALIQUOTS EACH) WHICH LEFT THE CUSTOMERS CONTROL AND MAY HAVE BEEN AFFECTED. THIS REPORTED WELD PRODUCED AN ORIGINAL PLUS 1 ALIQUOT. IT IS NOT KNOWN IF THESE WERE TRANSFUSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9377000 ↗
• MalfunctionNov 26, 2019Use of Device Problem; Break; Leak/Splash; Use of Device Problem

  THE CUSTOMER REPORTED THAT WHILE USING THE TSCDII WELDER TO PROCESS PACKED CELL PRODUCTS THE WELDER WAS NOT EJECTING THE WAFER AFTER SEALING WAS COMPLETE. PER THE CUSTOMER, THE OPERATOR PERFORMED 9 WELDS BEFORE THEY NOTICED THE WELDS HAD A STRINGY MATERIAL WHEN REMOVED FROM THE WELDER JAWS. AT THIS TIME, THE OPERATOR NOTICED THE WAFER DID NOT EJECT, AND IT WAS REPORTED WAS STATED THE WAFER LOOKED "DAMAGED". THE CUSTOMER EXPRESSED CONCERN FOR THE STERILITY OF THE PRODUCTS. PER THE CUSTOMER, THE FIRST WELD LEAK WAS NOTICED ON (B)(6) 2019, THE 2ND WELD LEAK WAS FOUND ON (B)(6) 2019 AND THE DEVICE WAS TAKEN OUT OF SERVICE THE SAME DAY. IT IS UNKNOWN AT THIS TIME WHAT THE DISPOSITION OF THE PRODUCTS WAS OR IF THEY WERE USED ON A PATIENT, PER THE CUSTOMER, NO TESTING WAS PERFORMED ON THE UNITS. THE CUSTOMER DECLINED TO PROVIDE PATIENT INFORMATION OR OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9376998 ↗
• MalfunctionNov 26, 2019Use of Device Problem; Break; Leak/Splash; Use of Device Problem; Ejection Problem

  DURING FOLLOW-UP WITH THE CUSTOMER IT WAS REPORTED THAT WHEN THE CUSTOMER FIRST NOTICED THAT THE WAFER DID NOT ADVANCE, THEY CHECKED THEIR LOG AND FOUND 2 RECENT WELD FAILURES DOCUMENTED. FROM THE FIRST TO THE LAST, THERE WERE A TOTAL OF 9 WELDS A TOTAL OF 6 DONOR UNITS. EACH WELD RESULTED IN AN ORIGINAL PRODUCT AND THE NEW ALIQUOT, SO EACH AFFECTED WELD POTENTIALLY AFFECTS 2-3 PARTIAL UNITS. IT WAS REPORTED THAT IF THE REMAINDER OF THE ORIGINAL BAG WAS STILL IN THE REFRIGERATOR AT THE CUSTOMER SITE, IT WAS DISCARDED. IF EITHER THE ORIGINAL BAG OR THE ALIQUOT HAD BEEN TRANSFUSED TO A PATIENT, IT WAS NOTED, AND THESE WERE THE ONES REPORTED TO FDA. THE CUSTOMER REPORTED 8 ALIQUOTS ON 6 DIFFERENT UNITS OF BLOOD (2 UNITS HAD 2 ALIQUOTS EACH) WHICH LEFT THE CUSTOMERS CONTROL AND MAY HAVE BEEN AFFECTED. THIS REPORTED WELD PRODUCED AN ORIGINAL PLUS 2 ALIQUOTS. IT IS NOT KNOWN IF THESE WERE TRANSFUSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9376991 ↗
• MalfunctionNov 26, 2019Use of Device Problem; Break; Leak/Splash; Use of Device Problem; Ejection Problem

  DURING FOLLOW-UP WITH THE CUSTOMER IT WAS REPORTED THAT WHEN THE CUSTOMER FIRST NOTICED THAT THE WAFER DID NOT ADVANCE, THEY CHECKED THEIR LOG AND FOUND 2 RECENT WELD FAILURES DOCUMENTED. FROM THE FIRST TO THE LAST, THERE WERE A TOTAL OF 9 WELDS A TOTAL OF 6 DONOR UNITS. EACH WELD RESULTED IN AN ORIGINAL PRODUCT AND THE NEW ALIQUOT, SO EACH AFFECTED WELD POTENTIALLY AFFECTS 2-3 PARTIAL UNITS. IT WAS REPORTED THAT IF THE REMAINDER OF THE ORIGINAL BAG WAS STILL IN THE REFRIGERATOR AT THE CUSTOMER SITE, IT WAS DISCARDED. IF EITHER THE ORIGINAL BAG OR THE ALIQUOT HAD BEEN TRANSFUSED TO A PATIENT, IT WAS NOTED, AND THESE WERE THE ONES REPORTED TO FDA. THE CUSTOMER REPORTED 8 ALIQUOTS ON 6 DIFFERENT UNITS OF BLOOD (2 UNITS HAD 2 ALIQUOTS EACH) WHICH LEFT THE CUSTOMERS CONTROL AND MAY HAVE BEEN AFFECTED. THIS REPORTED WELD PRODUCED AN ORIGINAL PLUS 1 ALIQUOT. IT IS NOT KNOWN IF THESE WERE TRANSFUSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9376987 ↗
• MalfunctionNov 26, 2019Use of Device Problem; Break; Use of Device Problem; Activation, Positioning or Separation Problem

  THE CUSTOMER REPORTED THAT WHILE USING THE TSCDII WELDER TO PROCESS PACKED CELL PRODUCTS THE WELDER WAS NOT EJECTING THE WAFER AFTER SEALING WAS COMPLETE. PER THE CUSTOMER, THE OPERATOR PERFORMED 9 WELDS BEFORE THEY NOTICED THE WELDS HAD A STRINGY MATERIAL WHEN REMOVED FROM THE WELDER JAWS. AT THIS TIME, THE OPERATOR NOTICED THE WAFER DID NOT EJECT, AND IT WAS REPORTED WAS STATED THE WAFER LOOKED "DAMAGED". THE CUSTOMER EXPRESSED CONCERN FOR THE STERILITY OF THE PRODUCTS. PER THE CUSTOMER, THE FIRST WELD LEAK WAS NOTICED ON (B)(6) 2019, THE 2ND WELD LEAK WAS FOUND ON (B)(6) 2019 AND THE DEVICE WAS TAKEN OUT OF SERVICE THE SAME DAY. IT IS UNKNOWN AT THIS TIME WHAT THE DISPOSITION OF THE PRODUCTS WAS OR IF THEY WERE USED ON A PATIENT, PER THE CUSTOMER, NO TESTING WAS PERFORMED ON THE UNITS. THE CUSTOMER DECLINED TO PROVIDE PATIENT INFORMATION OR OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9376985 ↗
• MalfunctionNov 26, 2019Use of Device Problem; Leak/Splash; Use of Device Problem; Ejection Problem

  THE CUSTOMER REPORTED THAT WHILE USING THE TSCDII WELDER TO PROCESS PACKED CELL PRODUCTS THE WELDER WAS NOT EJECTING THE WAFER AFTER SEALING WAS COMPLETE. PER THE CUSTOMER, THE OPERATOR PERFORMED 9 WELDS BEFORE THEY NOTICED THE WELDS HAD A STRINGY MATERIAL WHEN REMOVED FROM THE WELDER JAWS. AT THIS TIME, THE OPERATOR NOTICED THE WAFER DID NOT EJECT, AND IT WAS REPORTED WAS STATED THE WAFER LOOKED "DAMAGED". THE CUSTOMER EXPRESSED CONCERN FOR THE STERILITY OF THE PRODUCTS. PER THE CUSTOMER, THE FIRST WELD LEAK WAS NOTICED ON (B)(6) 2019, THE 2ND WELD LEAK WAS FOUND ON (B)(6) 2019 AND THE DEVICE WAS TAKEN OUT OF SERVICE THE SAME DAY. IT IS UNKNOWN AT THIS TIME WHAT THE DISPOSITION OF THE PRODUCTS WAS OR IF THEY WERE USED ON A PATIENT, PER THE CUSTOMER, NO TESTING WAS PERFORMED ON THE UNITS. THE CUSTOMER DECLINED TO PROVIDE PATIENT INFORMATION OR OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9376984 ↗
• MalfunctionNov 26, 2019Use of Device Problem; Break; Leak/Splash; Product Quality Problem; Use of Device Problem; Failure to Eject

  THE CUSTOMER REPORTED THAT WHILE USING THE TSCDII WELDER TO PROCESS PACKED CELL PRODUCTS THE WELDER WAS NOT EJECTING THE WAFER AFTER SEALING WAS COMPLETE. PER THE CUSTOMER, THE OPERATOR PERFORMED 9 WELDS BEFORE THEY NOTICED THE WELDS HAD A STRINGY MATERIAL WHEN REMOVED FROM THE WELDER JAWS. AT THIS TIME, THE OPERATOR NOTICED THE WAFER DID NOT EJECT, AND IT WAS REPORTED WAS STATED THE WAFER LOOKED "DAMAGED". THE CUSTOMER EXPRESSED CONCERN FOR THE STERILITY OF THE PRODUCTS. PER THE CUSTOMER, THE FIRST WELD LEAK WAS NOTICED ON (B)(6) 2019, THE 2ND WELD LEAK WAS FOUND ON (B)(6) 2019 AND THE DEVICE WAS TAKEN OUT OF SERVICE THE SAME DAY. IT IS UNKNOWN AT THIS TIME WHAT THE DISPOSITION OF THE PRODUCTS WAS OR IF THEY WERE USED ON A PATIENT, PER THE CUSTOMER, NO TESTING WAS PERFORMED ON THE UNITS. THE CUSTOMER DECLINED TO PROVIDE PATIENT INFORMATION OR OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9376981 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem

  DURING A TERUMO BCT REVIEW OF THE TRANSFUSION JOURNAL, ¿BACTERIAL SCREENING OF PLATELET COMPONENTS BY NATIONAL HEALTH SERVICE BLOOD AND TRANSPLANT, AN EFFECTIVE RISK REDUCTION MEASURE.¿ RESEARCHERS: CARL MCDONALD, JENNIFER ALLEN, SUSAN BRAILSFORD, ANJANA ROY, JOANNE BALL,RICHARD MOULE, MARIZA VASCONCELOS, RACHAEL MORRISON, AND TYRONE PITT PERFORMED BACTERIAL SCREENING ON PLATELET (PLT) COMPONENTS IN FIVE REGIONAL NATIONAL HEALTH SERVICE BLOOD AND TRANSPLANT (NHSBT) SITES. THE SITES WERE: BRISTOL, MANCHESTER, SHEFFIELD, NEW CASTLE, AND LONDON. ALL 250,000 APHERESIS PLT PRODUCTS WERE COLLECTED ON THE TRIMA SYSTEM. A SINGLE CONFIRMED REPORT OF BACTERIAL TRANSMISSION WAS NOTED BY THE CLINICAL TEAM ASSOCIATED WITH A 6-DAY-OLD POOLED PRODUCT, WHICH WAS REPORTED IN THE SCREENING PERIOD. THE RECIPIENT NOTED IN THIS REPORT WAS AN ELDERLY NEUTROPENIC PATIENT WITH ACUTE MYELOGENOUS LEUKEMIA WHO DEVELOPED RIGORS AND FEVER WITHIN 15 MINUTES OF THE START OF THE PLT TRANSFUSION DUE TO CONTAMINATION WITH S. AUREUS AND RECOVERED AFTER PROMPT TREATMENT. THE 50,000 POOLED PRODUCTS (POOLED PRODUCTS WERE MADE FROM FOUR DONATIONS) WERE STERILE CONNECTED USING THE TSCD II DEVICE. DUE TO EU PERSONAL DATA

  Patient problems: Chills; Fever; Reaction

  MAUDE report 8189937 ↗
• MalfunctionDec 21, 2018Adverse Event Without Identified Device or Use Problem; Microbial Contamination of Device; Adverse Event Without Identified Device or Use Problem

  DURING A TERUMO BCT REVIEW OF THE TRANSFUSION JOURNAL ARTICLE, ¿BACTERIAL SCREENING OF PLATELET COMPONENTS BY NATIONAL HEALTH SERVICE BLOOD AND TRANSPLANT, AN EFFECTIVE RISK REDUCTION MEASURE.¿ RESEARCHERS: CARL MCDONALD, JENNIFER ALLEN, SUSAN BRAILSFORD, ANJANA ROY, JOANNE BALL,RICHARD MOULE, MARIZA VASCONCELOS, RACHAEL MORRISON, AND TYRONE PITT PERFORMED BACTERIAL SCREENING ON PLATELET (PLT) COMPONENTS IN FIVE REGIONAL NATIONAL HEALTH SERVICE BLOOD AND TRANSPLANT (NHSBT) SITES. THE SITES WERE: (B)(6). THE 50,000 POOLED PRODUCTS (POOLED PRODUCTS WERE MADE FROM FOUR DONATIONS) WERE STERILE CONNECTED USING THE TSCD II DEVICE. THE FOLLOWING BACTERIAL TEST RESULTS FROM POOLED PRODUCTS WERE REPORTED FROM FEBRUARY 2011 TO SEPTEMBER 2015:195 CONFIRMED POSITIVES160 INDETERMINATE POSITIVES 183 INDETERMINATE NEGATIVES DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. THIS DEVICE IS NOT AVAILABLE FOR EVALUATION BY TERUMO BCT. THE AUTHOR OF JOURNAL ARTICLE DECLINED TO PROVIDE PROCEDURAL DETAILS, PATIENT INFORMATION, AND PATIENT OUTCOME/FACTORS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8189924 ↗