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

Catalog Number 10220

Device Problems Misassembled (1398); Device Displays Incorrect Message (2591); Device Misassembled During Manufacturing /Shipping (2912); Installation-Related Problem (2965)

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

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer submitted a photograph of the disposables set to terumo bct.Terumo bct customer support determined from the photo that the disposable set was used on the patient as there was blood in the set.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a collection procedure on a spectra optia device, they noticed the roller clamp on the normal saline line green line, was on the return line after they received a high return alarm and they followed the flow process from the patient.It was reported by the customer that the patient may have received about 50 mls of saline because the patient's access was clamped after the high return pressure alarm so that the patients access could be checked again.Per the customer, the patient is no longer admitted and has been discharged.Patient info and outcome are not available at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Images were submitted to terumo bct in lieu of the disposable tubing set.The picture comfirms that the return saline line clamp (blue) is on the return line.Correction: terumo bct has implemented a correction for this incident.Manufacturing staff were made aware of this issue and retrained to the appropriate procedures.The retraining is documented in terumo bct¿s electronic training database under this quality record.Training was completed on 1/22/2020.Root cause: based on the customer's description of events, the root cause was related to a manufacturing defect, the roller clamp was on the wrong line.

Event Description

The customer did not respond to multiple attempts to obtain information for the investigation such as patient information, outcome, or procedural details.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9179883
• MDR Text Key: 188244311
• Report Number: 1722028-2019-00296
• 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: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• 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: 10220
• Device Lot Number: 1904303230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other