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

Catalog Number 12220

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that an expired set as used for a procedure.The date of the procedure was (b)(6) 2021, the disposables set expired 11/01/2020.Per the customer, no serious injury occured and no medical intervention was required for this event.Patient information is not available at this time.The disposable set is not available for return because it was discarded by the customer.

Event Description

The customer originally reported that they received an "anticoagulant tubing does not recognized liquid alarm".While terumo bct was looking into the reported alarm, it was found that an expired set had been used.The customer reported that the alarm occurred during priming, prior to a patient being connected.There was not a patient involved in the incident, therefore no patient information is reasonably known.Eu personal data protection laws are applicable for this event.

Manufacturer Narrative

Investigation: the 'ac fluid detector did not detect fluid' alarm occurs if the ac fluid detector did not detect fluid and thus, the system could not prime the ac line.This alarm may be continued by the operator.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.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Correction: terumo bct regional sales account manager followed-up with the customer concerning the event and retraining was completed on (b)(6) 2021.Root cause: the root cause for the customer inadvertently using expired tubing sets was determined to be due to operator error.A definitive root cause for the non reportable prime failures could not be determined.Possible causes include but are not limited to: - ac line was not properly flossed in the ac fluid detector.- ac line was obstructed, or ac container was not properly spiked.- ac tubing has dent/kink or fluid on it causing improper reading.- debris was on the ac fluid detector.- defective ac fluid sensor.- defective ac pump motor.- defective ultrasonics/safety board.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11607765
• MDR Text Key: 244869821
• Report Number: 1722028-2021-00137
• 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,Followup
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: 12220
• Device Lot Number: 1811073330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other