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

Catalog Number 12320

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

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

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a saline roller clamp was not closed while performing a procedure on a spectra optia device.It is unknown if medical intervention was required for this event.Patient information and outcome are unknown at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The procedural cautions section of the spectra optia apheresis system essentials guide 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.Investigation is in process.A follow-up report will be provided.

Event Description

After multiple follow-up attempts, the customer did not provide additional procedural details, including exact incident date.

Event Description

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

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6 and h.10.Corrected information is provided in e.1.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to: saline clamp left partially open by the operator - a defective clamp, which failed to fully occlude the line - a manufacturing mis-assembly where the assembler neglected to follow the appropriate manufacturing operating procedure of the disposable set during manufacturing.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9363077
• MDR Text Key: 188116250
• Report Number: 1722028-2019-00366
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• 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: 11/22/2019

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 Catalogue Number: 12320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 12/23/2019; 12/23/2019
• Supplement Dates FDA Received: 12/17/2019; 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other