MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA SINGLE NEEDLE CONNECTOR

Catalog Number 11220

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the air got trapped right in the y-section of the disposables set and blood warmer tubing is not being used at this location.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a single needle red blood cell exchange procedure (snrbcx) an air bubble appeared in the sn adapter that was difficult to clear during prime on a spectra optia set.Per the customer, no air was returned to the patient as the operator flushed multiple times and flicked the adapter to get the air out.Patient information is not available at this time.The exchange set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide in investigation: a review of the device history record (dhr) for this unit showed no irregularitiesduring manufacturing that were relevant to this issue.Per the optia training presentation for single needle tpe procedures, the operator is reminded tocheck the inlet and return lines for air after priming the connector and before connecting thepatient.The customer submitted a photograph of a single needle adapter, still within its packaging, toterumo bct to illustrate where the air bubble was observed.Root cause: based on the clinical findings, a definitive root cause could not be determined.Possible causes include but are not limited to:-failure to properly prime the y connector-unidentified manufacturing defect.

Event Description

Per follow up with the customer, the air was observed prior to connecting a patient, therefore,no patient (donor) was connected at the time of the event and no patient information isreasonably known.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA SINGLE NEEDLE CONNECTOR
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8969953
• MDR Text Key: 165051543
• Report Number: 1722028-2019-00255
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

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 Expiration Date: 04/01/2021
• Device Catalogue Number: 11220
• Device Lot Number: 1904095130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 09/26/2019
• Supplement Dates FDA Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other