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

Catalog Number 12220

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problems Hypovolemia (2243); No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: one used return line and return line manifold component from an optiadisposable set was returned to terumo bct for evaluation.Visual inspection confirmed blood in the returned components.The luer section of the return line was noted to not have been bonded to the return line manifold.A solvent witness mark was evident on the manifold bond socket of approximately 1mm.This indicates the component may not have been bonded as prespecification.Investigation is in process.A follow-up report will be provided.

Event Description

A customer reported that a patient was undergoing a therapeutic plasma exchange (tpe)procedure using a secondary plasma device (spd).During the procedure, the patient stated she felt something warm flowing over her back.Upon inspection, the attending nurse found the tubing with the blue clamp had come off the connector on the venous part of the tubing set.The procedure was ended without rinse back and the patient was disconnected.The customer reported that the patient was "okay".No medical intervention was required for this event.Patient weight is not available at this time.

Manufacturer Narrative

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

Event Description

During follow-up with the customer, it was reported that following the procedure a blood gas analysis was completed to analyze the amount of blood lost for this event.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: two arterial blood gas analysis were conducted to determine blood loss and values were as follows: bga-hct (%) = 37.5% bga-po2(t) (mmhg) = 45.6% bga-so2 (%) = 81.5% po2 and so2 were outside the normal ranges.However, the customer confirmed that the patient was asymptomatic and no further medical intervention was required for the blood loss.The patient's blood loss was calculated using the blood gas analysis provided and procedure information/values and was determined to be approximately 741.79ml (20.2% patient fluid loss).One return line and return needle line containing blood product were received for investigation.Initial observation confirmed that the return needle line had become detached from the 2-1 manifold on the return line.The presence of dried blood could be observed around the tubing end of the needle line.Further examination of the component identified minimal evidence of solvent application and there were no clear witness marks to indicate insertion length of the tubing.The run data file (rdf) was analyzed for this event.Rdf analysis confirmed that there were no unusual alarms or events that occurred during the procedure and that the machine operated as intended.The leak in the disposable tubing set occurred at the end of the return line closest to the patient so slight pressure fluctuations are undetectable by the system.Review of the return pressure sensor readings did not show a discernable change in signal value.Root cause: based on the evidence found in the return part evaluation, the root cause for the leak at the 2-1 manifold was determined to be the result of a manufacturing defect in which insufficient solvent application occurred.Correction: a correction was implemented for this incident: manufacturing staff were retrained to the appropriate procedures.

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

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7527329
• MDR Text Key: 108941201
• Report Number: 1722028-2018-00141
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K153601
• 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: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Catalogue Number: 12220
• Device Lot Number: 1801113230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2018
• 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: 59 YR
• Patient Weight: 62