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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TSCDII; 3ME-SC203A TSCDII 110V
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TERUMO BCT TSCDII; 3ME-SC203A TSCDII 110V Back to Search Results
Model Number 3MESC203A
Device Problems Break (1069); Leak/Splash (1354); Product Quality Problem (1506); Use of Device Problem (1670); Failure to Eject (4010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation: per terumo bct customer support, the tscdii device detects the movement of the arm that inserts the wafers but not the actual wafer movement.It was suggested to the customer to follow the recommendations of removing the waste drawer to monitor the wafer removal.Per the customer, one of their staff members believes a small piece of tubing fell into the instrument.Three used wafers and one used wafer cartridge were returned to terumo bct for investigation.Visual inspection revealed a sticky substance on the used wafers.No anomalies were noted on the wafer cartridge.The wafers in the cartridge were able to slide out of the cartridge with no issues.Additionally, two pieces of tubing containing blood were returned.One of the welds on the end of the tubing was leaking.All welds had the appearance of poor welds.Investigation is in process.A follow-up report will be provided.
 
Event Description
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.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: per the tscd ii quick reference guide, if a weld produces small pieces of tubing waste, there is a high risk that these small pieces of tubing will fall into the welder.Because there are multiple moving components located underneath the clamp opening, small pieces of tubing in this area may interfere with the moving components during the weld cycle.It is recommended that, upon inspecting each weld for integrity, the customer carefully removes and discards waste segments.Retraining was not provided to the customer since they identified the cause of the failure and their discussion with terumobct customer support indicated their corrective action had resolved the issue.Root cause: based on the customer's statements, the device service, as well as the evaluation of the wafers, the root cause of this failure was a small piece of tubing had fallen into the wafer outlet portion of the instrument, impeding the wafer advancement.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: the device was sent to terumobct for repair due to the failure of the welder to advance the wafers, leading to multiple welds being made with same wafer.The service technician was unable to confirm the reported issue.The device made welds; however, the welds have low pull forces.Welds were confirmed to have plastic filaments streaming from them.The service technician realigned the wafer holder and both clamps.A functional checkout was completed and the device passed the gb/lc test.One year of service history was reviewed for this device with no issues related to the reported condition identified.Investigation is in process.A follow-up report will be provided.
 
Manufacturer Narrative
Investigation: the tscdii design uses a wafer to cut the tubing, whereby it melts the two ends of the tubing from the opposing bags at 300+/-50c, and then presses the molten ends together forming a seal.The weld time is 14 seconds.It is unlikely a microbial contaminant could withstand the temperature of the wafer and tubing and therefore, a sterile connection is formed.The device serial number history report indicates no further related issues have been reported for this device.Investigation is in process, a follow-up report will be provided.
 
Event Description
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.
 
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Brand Name
TSCDII
Type of Device
3ME-SC203A TSCDII 110V
Manufacturer (Section D)
TERUMO BCT
lakewood CO 80215
MDR Report Key9376981
MDR Text Key188114658
Report Number1722028-2019-00386
Device Sequence Number1
Product Code KSB
UDI-Device Identifier05020583300033
UDI-Public05020583300033
Combination Product (y/n)N
PMA/PMN Number
BK110071
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3MESC203A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2019
Was the Report Sent to FDA? Yes
Date Manufacturer Received03/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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