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

Catalog Number 10220

Device Problems Backflow (1064); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/11/2020

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 that during a therapeutic plasma exchange (tpe), the operator inadvertently forgot to close the return saline roller and unclamped the return side to the patient.They stated that it was for approximately 4 minutes, then the operator closed the saline roller and opened the return line clamp.Per the customer, few cells went into the saline bag.Per the customer, the saline bag was 1000ml.Donor information and outcome are not available at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h6 & h10.Investigation: the customer did not provide the tbv of the patient or any run parameter information.It is also unknown if custom prime was performed.Assuming custom prime was not performed, the patient had a below average tbv of 2500 ml, and the inlet volume was running at the maximum rate of 142 ml/min, the worst case fluid loss for a normal individual is calculated to be 77%.(2500 ml - (142 ml/min x 4 min) / 2500 = 0.77 x 100 = 77% the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Correction: the customer requested that there be no further contact regarding this incident.No re-training was provided.Investigation is in process.A follow up report will be provided.

Event Description

The customer declined to provide patient information.There was no indication that the patient experienced adverse consequences or required medical intervention for the blood volume loss.

Manufacturer Narrative

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 blood lose was not greater than 2%.Estimated blood loss in return saline line from 2-1 manifold including drip chamber = 50 ml (12.49 ml + 11.8 ml + 22 ml = 46.3 ml) the customer stated that a few cells went into the saline bag so the blood loss is rounded up to 50 ml for the worst case scenario.Estimated blood loss due to clamping error = 50 ml / 2500 ml x 100% = 2% the customer was primarily concerned about the saline bag being contaminated with blood, and whether they could still use the saline.There was no indication they were concerned about the fluid balance of the patient.Root cause: based on the clinical findings and customer statements, the root cause of the blood in the saline bag was a failure of the operator to follow optia screen prompts to close the return saline roller clamp and open the return line clamp.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO
• MDR Report Key: 10477818
• MDR Text Key: 209583944
• Report Number: 1722028-2020-00419
• 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): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• 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
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other