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

Catalog Number 10310

Device Problems Hole In Material (1293); Leak/Splash (1354); Defective Component (2292); Device Displays Incorrect Message (2591); No Apparent Adverse Event (3189)

Patient Problems Hematoma (1884); No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: a spectra optia idl set was recevied for investigation.Upon visual inspection,blood was present throughout the cassette, return reservoir and channel.The ac and saline dripchambers had been rf sealed and removed.It was also noted that the customer had tapedquaze to a section of the return line.A leak was identified on the return line tubing approximately53mm from the return manifold.The leak location was examined under magnification and the presence of two small pinholes on either side of the return tubing were observed.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a patient experienced hematoma during a spectra optia apheresisprocedure.Approximately 105 minutes into the procedure, they received a 'return pressureerror' alarm and observed a leak on the patient's bed from a small hole on the return tubingline.The operator stopped and aborted the procedure.It is unknown at this time if medicalintervention was required for this event.Patient's full identifier (id): (b)(6).Patient's age and outcome are not available at this time.

Manufacturer Narrative

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

Event Description

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

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: no adverse event occurred as a result of this reported event.Based on the evidence found during the returned part investigation, a definitive root cause for the reported leak in the set could not be determined at this time.Possible causes relate to a leak in the return line as a result of a nick/tear may include but are not limited to:- defective tubing from the supplier/vendor- damage may have occurred during disposable manufacturing- tubing may get caught on other components during load that can cause nicks or tears- if the pinch clamp is defective or has a sharp edge (defect from supplier) and the clamp is closed onto the tubing a nick or tear in the tube can result.

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.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 confirmed that no patient injury or medical intervention occurred for the reported problem.

• 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: 7293309
• MDR Text Key: 100891308
• Report Number: 1722028-2018-00051
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: 10310
• Device Lot Number: 1708143130
• Other Device ID Number: 05020583103108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 06/14/2018; 10/09/2018; 11/02/2018
• Supplement Dates FDA Received: 06/15/2018; 10/30/2018; 11/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2017
• 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
• Patient Weight: 51