MAUDE Adverse Event Report: TERUMO BCT 3ME-SC203A TSCDII 110V

Model Number 3MESC203A

Device Problems Mechanical Problem (1384); Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer stated that while using the sealer device, the wafer cartridge was not loaded correctly resulting in multiple welds from the single-use wafer.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that post platelet procedure, a lab technician was attaching the tubing of the collected product using the sealer device.While the technician was attaching tubing, it was discovered that multiple welds were made from the single-use wafer.The customer is alleging a possible microbial contamination of the product.The customer stated that a patient was transfused with the product, however, specific dates of the platelet transfusion is not available at this time and it is unknown at this time if medical intervention was required for this event.Per the customer, the platelet products were collected on (b)(6) 2017 and lab processing was performed on (b)(6) 2017.Donor unit #: (b)(4).The customer declined to provide the patient weight and outcome.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Per terumo bct's internal risk documentation, the reported incident where the same cut/weld wafer was used in 18 tscd ii procedures to create 25 transfusable blood components, had the potential to lead to microbial infection and sepsis in the 20 patients transfused.The health risk is most likely low due to the heat generated by the wafer when the tscd ii device welds the pvc tubing together, killing any microbes present.As long as the used wafer reached a temperature of 300 ± 50 c for every procedure as monitored by the system, the probability of a viable microbe contaminating the resultant blood component is low and the risk of operator-exposure to blood borne pathogens due to a tubing seal leak is low.

Event Description

The customer declined to provide procedural details, patient weight, diagnosis, outcome and status per patient privacy regulations.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: terumo bct performed a use testing using an internal tscdii welder and was able to duplicate the reported condition.During the testing, two simultaneous evaluations were made.The first simultaneous evaluation was an issue of the cartridge switch.It was noted that if the switch senses that a wafer is in place, it will proceed to weld if there is no wafer present.This can occur if the cartridge is misloaded.The 2nd simultaneous evaluation was observed during the resistance check of the wafer.After performing a weld, the resistance of the wafer is changed and is checked to ensure a new wafer has been advanced.If the resistance check fails, the single-use wafer can be reused without the machine alarming.The tscdii welder was returned to terumo bct leuven for evaluation.However, an evaluation of the wafer cartridge could not be performed since the wafer cartridge was not returned for evaluation.A weld testing, leakage testing, and tensile strength test were performed using 3 internal tscdii welders with 2 different type of tubing.Test results indicated that the multiple welds that were made using a single-use wafer cartridge showed a direct negative impact on the quality of the weld.Internal asepsis test was also performed for 20 aliquots using the same wafer cartridge.Test results indicated that the asepsis was secured.Root cause: the root cause for this failure was identified as one of the two possible issues.If the device can make multiple welds with 1 wafer 2 faults have to occur: the used wafer is still within spec: temperature/resistance still in range; the feeding mechanism isn¿t working properly.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: terumo bct performed a use testing using a tscdii welder and was able to duplicate the reported condition.During the testing, two simultaneous evaluations were made.The first simultaneous evaluation was an issue of the cartridge switch.It was noted that if the switch senses that a wafer is in place, it will proceed to weld if there is no wafer present.This can occur if the cartridge is misloaded.The 2nd simultaneous evaluation was observed during the resistance check of the wafer.After performing a weld, the resistance of the wafer is changed and is checked to ensure a new wafer has been advanced.If the resistance check fails, the single-use wafer can be reused without the machine alarming.No additional complaints have been received for this machine regarding the reported condition.A review of the last year of service history for this device indicated no other reports related to this issue.Investigation is in process.A follow-up report will be provided.

• Brand Name: 3ME-SC203A TSCDII 110V
• Type of Device: TSCDII 110V
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6832141
• MDR Text Key: 85159889
• Report Number: 1722028-2017-00344
• Device Sequence Number: 0
• Product Code: KSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK160108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3MESC203A
• Other Device ID Number: 05020583300033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR