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

Catalog Number 10220

Device Problems Free or Unrestricted Flow (2945); Improper Flow or Infusion (2954); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/28/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture date and expiry are not available at this time.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that while performing a therapeutic plasma exchange (tpe)procedure on spectra optia, they received multiple 'low-level reservoir sensor detected excess fluid' alarms.The customer contacted terumo bct for troubleshooting and stated that they noticed that 500 ml of albumin bottle empty and there was not enough plasma present in the plasma bag.Per customer,they are not sure if the albumin went back to the patient.The customer reported that they discontinue the procedure, set up a new set and used a different machine.The support specialist asked the operator for saline rollers and found them closed.The patient is reported in the stable condition.The customer declined to provide any information regarding the patient or further procedural details.The tpe disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide in investigation: the customer did not provide the lot number pertaining to this event,therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide corrected information in e.3.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide in root cause: based off the information provided by the customer, the possible cause ofhypervolemia is the failure to remove fluid due to a kink, occlusion or clamping error results in noremoval of fluid.If nothing is being removed, but replacement fluid is being return to the patient,this would result in too much fluid being returned.It is also possible that the remove line was notsealed prior to raising the cassette, causing the plasma to drain back into the disposable set.Ifthis is the case, then there would be no concern of fluid balance.Alarm - low level sensor detected excess fluid, possible causes of the alarm include but are notlimited to:- reservoir contained foam- line in centrifuge was occluded/obstructed- remove line was obstructed- reservoir filter was obstructed- valve did not function correctly- tubing was not correctly loaded.

Event Description

Initially operator contacted terumo bct to troubleshoot 'low-level reservoir sensor detectedexcess fluid' alarms , and then called back again to troubleshoot 'aim system could notestablish target interface' alarm.The operator stated he pressed continue everytime afterhaving level sensor alarms.The tbct customer support provided troubleshooting for eachreported alarm.The customer did not respond to multiple attempts to obtain information for the investigationsuch as procedural details, patient information, and lot information and no medical interventionwas reported for this event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8723102
• MDR Text Key: 149065477
• Report Number: 1722028-2019-00151
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/21/2019

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 Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/21/2019
• Supplement Dates Manufacturer Received: 07/15/2019; 08/22/2019; 09/20/2019
• Supplement Dates FDA Received: 07/16/2019; 08/30/2019; 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other