MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Catalog Number 10220

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hemolysis (1886)

Event Date 07/01/2023

Event Type  malfunction  

Event Description

The customer called terumo bct customer support to report that during a therapeutic plasma exchange (tpe) procedure cells were detected in the plasma line in centrifuge.The operator wasn't able to see the separation in the channel.The patient diagnosis is r/o thrombotic thrombocytopenic purpura (ttp).Terumo bct customer support suggested the operator check the fluids hanging and when they did they were appropriate the operator was able to provide a photo it took a while but she was able to send a picture of the interface.The plasma was orange tinged and the rbc layer was low.The operator lost telephone connection while terumo bct customer support was waiting on the picture and when they finally received the picture and were able to get in touch with the operator, they had started rinse back on the patient.Terumo bct customer support suggested to the operator they needed to contact the physician to find out if they wanted the procedure to be continued.If the procedure is to be continued because the discolored plasma is disease related the operator can disable the rbc detector when they restart the procedure after having the alarm disabled.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Lot number and expiry information are not available at this time investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the customer submitted a photograph to aid the investigation.The photograph shows the interface through the viewport and confirms the plasma in the connector is orange tinged and there is hemolysis.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Investigation is in process, a follow-up report will be provided.

Event Description

The customer called terumo bct customer support to report that during a therapeutic plasma exchange (tpe) procedure cells were detected in the plasma line in centrifuge.The operator wasn't able to see the separation in the channel.The patient diagnosis is r/o thrombotic thrombocytopenic purpura (ttp).Terumo bct customer support suggested the operator check the fluids hanging and when they did they were appropriate the operator was able to provide a photo it took a while but she was able to send a picture of the interface.The plasma was orange tinged and the rbc layer was low.The operator lost telephone connection while terumo bct customer support was waiting on the picture and when they finally received the picture and were able to get in touch with the operator, they had started rinse back on the patient.Terumo bct customer support suggested to the operator they needed to contact the physician to find out if they wanted the procedure to be continued.If the procedure is to be continued because the discolored plasma is disease related the operator can disable the rbc detector when they restart the procedure after having the alarm disabled.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information inb.5, h.6 and h.10.Investigation: the customer submitted a photograph to aid the investigation.The photograph shows the interface through the viewport and confirms the plasma in the connector is orange tinged and there is hemolysis.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause investigation and conclusion: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause for hemolysis could not be determined but it is likely due to one or a combination of the possible causes listed below: * patient's underlying disease state.Patient's medication and/or medical treatment.Hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.Hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.Hemolysis due to pinched return line resulting in rbcs exposed to pressure drop in return line.Hemolysis due to pinched inlet line resulting in rbcs exposed to pressure drop in inlet line.The residual total risk is determined to be low.Hemolysis due to an occlusion in the tubing resulting in rbcs exposed to a pressure drop.

Event Description

The customer called terumo bct customer support to report that during a therapeutic plasma exchange (tpe) procedure cells were detected in the plasma line in centrifuge.The operator wasn't able to see the separation in the channel.The patient diagnosis is r/o thrombotic thrombocytopenic purpura (ttp).Terumo bct customer support suggested the operator check the fluids hanging and when they did they were appropriate the operator was able to provide a photo it took a while but she was able to send a picture of the interface.The plasma was orange tinged and the rbc layer was low.The operator lost telephone connection while terumo bct customer support was waiting on the picture and when they finally received the picture and were able to get in touch with the operator, they had started rinse back on the patient.Terumo bct customer support suggested to the operator they needed to contact the physician to find out if they wanted the procedure to be continued.If the procedure is to be continued because the discolored plasma is disease related the operator can disable the rbc detector when they restart the procedure after having the alarm disabled.After multiple follow-ups to obtain the patient's information, no response was received.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 17389286
• MDR Text Key: 319788238
• Report Number: 1722028-2023-00255
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other