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

Catalog Number 10310

Device Problem Human-Device Interface Problem (2949)

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

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.The procedural cautions section of the spectra optia apheresis system essentials guide ((b)(4)), pg 11, states that if the roller clamp on the saline line is left completely open when the patient is connected, the patient will be quickly infused with a large volume of saline.Root cause: based on the clinical findings, the root cause was related to the operator's failure to follow the screen prompt to close the inlet saline roller clamp at the end of prime divert.

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection on the spectra optia, the operator was having issues establishing the interface.The operator contacted a clinical specialist at terumo bct to assist her and was able to establish the interface, close the inlet saline roller clamp and continue the procedure.Per the customer, the patient was in stable condition.The customer did not respond to multiple attempts to obtain patient id, date of birth, weight and more information for the investigation, including post procedure total blood volume (tbv).The cmnc spectra optia collection set was not available for return because it was discarded by the customer.

• 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: 7857379
• MDR Text Key: 119653846
• Report Number: 1722028-2018-00244
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• 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: 05/01/2020
• Device Catalogue Number: 10310
• Device Lot Number: 1805303130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2018
• 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