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

Model Number 10220

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem Hemolysis (1886)

Event Date 11/25/2022

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry are not available at this time.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported hemolysis during a therapeutic plasma exchange (tpe) procedure.The patient has thrombotic thrombocytopenic purpura (ttp) and the plasma is red.The adams 13 is elevated.Per physician order, the procedure was continued.Per the physician at the customer site, the hemolysis likely occurred due to the patient having ttp.Patient information and outcome are not available at this time.The exchange set is not available for return for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6 and h.10.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.It was confirmed that the physician at the customer site identified the hemolysis occurred due to the patient having ttp, not the procedure.The disposable set was not returned to terumo bct for investigation.The customer submitted a photograph of the connector (looking through the viewport), hemolysis is visible inside the connector.Lot number and expiry are not available at this time.Root cause: a root cause assessment was performed for this complaint.Based on the available information, the root cause of the hemolysis relates to the patient¿s disease state.No further reporting will be provided as this does not represent a reportable event.

Event Description

The customer reported hemolysis during a therapeutic plasma exchange (tpe) procedure.The patient has thrombotic thrombocytopenic purpura (ttp) and the plasma is red.The adams 13 is elevated.Per physician order, the procedure was continued.He physician indicated the hemolysis occurred due to the patient having ttp.The exchange set is not available for return for evaluation.

• 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: 16005094
• MDR Text Key: 308551309
• Report Number: 1722028-2022-00410
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• 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
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10220
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 01/12/2023
• 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