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

Catalog Number 10310

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the saline stopped dripping during the procedure and approximately 600 ml were left in the saline bag.Investigation is in process.A follow-up report will be submitted.

Event Description

The customer reported that at the beginning of a continuous mononuclear cell (cmnc)collection procedure, they noticed that the saline was running.They discovered that they had left the saline roller clamp open.The operator closed the saline roller clamps and successfully completed the procedure.The patient (donor) is reported in stable condition.Patient (donor) id is not available at this time.The cmnc collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.

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.Review of the run data file (rdf) showed that the final fluid balance was 113%.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to: incorrect clamping sequence during pressure test and priming process and tubing incorrectly loaded in pumps.

Manufacturer Narrative

This report is being filed tp provide additional information.Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf show that the optia system operated as intended and that the final fluid balance of the patient was 113%.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.

• 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: 6671866
• MDR Text Key: 78792327
• Report Number: 1722028-2017-00267
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/27/2017

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: 01/01/2019
• Device Catalogue Number: 10310
• Device Lot Number: 01A3125
• Other Device ID Number: 05020583103108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 06/27/2017
• Supplement Dates Manufacturer Received: 08/24/2017; 09/12/2017; 10/25/2017
• Supplement Dates FDA Received: 08/30/2017; 09/22/2017; 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2017
• 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 Age: 61 YR
• Patient Weight: 88