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

Catalog Number 10310

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591); No Apparent Adverse Event (3189)

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

Event Date 08/13/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer returned one used optia set for investigation.Visual inspection confirmed the set was assembled correctly with no kinks, leaks, occlusions or missing parts.Flow of blood was observed throughout the set and in the inlet line, cassette and channel.There was evidence of foam in the reservoir.No disposable defects were identified.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that during rinseback of a spectra optia collection procedure, the machine alerted ¿foam in the system¿, after about 138 ml, because of foam in the centrifuge area.Per the customer, rinseback was stopped because foam was also visible in the return tube, the procedure was ended, and the patient was disconnected.No injury occurred, and medical intervention was not required.Patient identifier, date of birth, gender and weight are 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 customer indicated that the new operator forgot to open the saline line during rinseback and the machine stopped the procedure without finishing the rinseback.The customer confirmed that there was no air in the return line.Root cause: based on the clinical findings, the air in the system during rinseback was caused by an operator error where the inlet saline clamp was not open to allow saline to rinse the blood contents back to the patient.Correction: terumo bct has provided assistance to the customer regarding the operator error.

Event Description

Due to eu personal data protection laws, the patient information is not available from the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7857413
• MDR Text Key: 120252535
• Report Number: 1722028-2018-00245
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2018

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: 04/01/2020
• Device Catalogue Number: 10310
• Device Lot Number: 1804103430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 10/01/2018; 10/18/2018
• Supplement Dates FDA Received: 10/01/2018; 10/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2018
• 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