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

Catalog Number 12220

Device Problems Loss of or Failure to Bond (1068); Break (1069); Fluid/Blood Leak (1250)

Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the reported final fluid balance (ffb) was 100%, however,they are unable to estimate the saline bolus.One optia exchange disposable with blood warmer attached was returned to terumo bct for investigation.Initial observations noted that the ac and saline drip chambers and remove bag had been rf sealed and removed prior to the return.Visual examination of the disposable set confirmed that the return tubing line had become detached from the 2-1 return manifold at the single side.Further examination of the return tubing line and bond socket observed the presence of solvent on the both the tubing and inner diameter of the bond socket.A witness mark present on the tubing line indicated that the tubing had been inserted approximately 5mm into the 10mm bond socket leaving a bond gap of approximately 50%.Reported patient statistics: total amount of fluids machine gave (displayed): ac vol; 26ml and fluid balance -19ml total fluids removed (displayed): 145ml total fluids removed/collected (measured): replace vol; 101 initial tbv: 1.0a 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 during plasma exchange procedure on spectra optia the return pump harness broke, causing blood to spill onto the circuit, the machine, the floor and on the patient.Per the customer, the procedure was paused manually as there were no alarms and post final blood count (fbc) was taken.Further blood testing was performed to evaluate the blood loss.The customer further stated that they completed the procedure with gloves and cleaned the machine.The patient was encouraged to increase the intake of oral fluids.The patient and nursing team were updated about the impact and machine was taken away to start the new procedure with another optia.Per the customer, the blood did not come into contact with non- intact skin or mucus membranes.The patient outcome is not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information.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.The final fluid balance does not present a risk of hypovolemia.% patient tbv fluid balance = -9.6% % fluid balance total: 90.4% correction: terumo bct manufacturing staff were made aware of this issue and retrained to the appropriate procedures.Root cause: based on the evidence found in the return part evaluation, the root cause for the leak at the 2-1 manifold was determined to be the result of a manufacturing defect in which insufficient solvent application occurred.

Event Description

Per the customer, the patient was in "in patient" status.Due to eu personal data protection laws, the patient outcome is not available from the customer.Per the customer, the results of the final blood count were 120g/l.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9129062
• MDR Text Key: 188238039
• Report Number: 1722028-2019-00281
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• 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: 1906113230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00076 YR
• Patient Weight: 70