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

Catalog Number 12220

Device Problems Contamination of Device Ingredient or Reagent (2901); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the patient had the same procedure before and his plasma was not this dark.The procedure is being done 4 weeks with only 4 units of rbc with over 2 l of replacement fluid because of the patient's size.The operator has tried to discuss with the physician ordering the full amount needed for the exchange with no results.Tbct customer support visually inspected the connector pictures provided by the customer and found dark yellow plasma and low rbc layer.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that at the beginning of the red blood cell exchange (rbcx)procedure, they received an ¿aim system detected rbc interface near top of channel¿ alarm and noted 'dark brown yellow' plasma in the connector and cassette that they described as hemolysis.The customer contacted terumo bct for troubleshooting.The customer stated that with hct at 27%, they did not see the separation of cells in the channel.Tbct customer support suggested the operator to lower the hct down to 24% and not to change the hct again unless they receive the alarm.The tbct customer support suggested the operator to notify the physician if the plasma color was due to the patient pre-existing condition.During subsequent follow-up with the customer, the operator confirmed that after notifying the physician, the decision was made to continue with the procedure.Per the customer,they checked the fluids during procedure and stated that patient tolerated the procedure 'fine' and is reported in the stable condition and 'discharged'.The spectra optia exchange set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide in updated informationin g.1 and g.2.Investigation: per follow up with the customer, the medical director at the customer sitebelieves the darkened color of plasma could be due to the more rapid turnover of cells seen insickle cell disease (scd) patients.Terumo clinical support suggested to the patient¿s physician toincrease the volume of rbc exchange fluid used, and also that some testing is done to rule out anautoimmune hemolytic anemia on top of his scd.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in investigation: further evaluation of this event has determined that the device did not causeor contribute to a death or serious injury, nor is there a likely potential for death or serious injuryassociated with this event based on additional investigational information.Per the customer'smedical director, the color of the plasma was related to the patient's underlying disease state.Nomedical intervention was performed.The customer provided pictures from the event to terumo bct for evaluation.Picture 1confirmed pink plasma in the plasma line and recirculation line.Pictures 2 and 3 confirmed pinkplasma in the connector.Picture 4 confirmed the alarm 'cells were detected in the plasma linefrom the centrifuge'.Root cause: based on the statement from the medical director, the root cause wasdetermined to be the result of the patient's underlying disease state.

Event Description

It was reported by the customer that there were no adverse events noted during theprocedure.The patient remained in stable condition after completion of the procedure.Per the customers medical director, the color of the plasma was related to the patient'sunderlying disease state.No medical intervention was performed.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8950002
• MDR Text Key: 165048109
• Report Number: 1722028-2019-00247
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 12220
• Device Lot Number: 1906053230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 08/30/2019; 10/11/2019
• Supplement Dates FDA Received: 09/24/2019; 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00016 YR
• Patient Weight: 54