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

Catalog Number 12220

Device Problems Device Alarm System (1012); Misassembled (1398); Reflux within Device (1522)

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

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: photographs were submitted in lieu of the disposable set to aid in the investigation.Analysis of the images revealed a used optia exchange set containing blood loaded on an optia machine.The cassette is in the lowered position.Rbcs are seen in the plasma collect lines and rbcs.The absence of rbcs in the rbc recirc line indicates the channel rbc line was clotted off.Solvent occlusion is ruled out because the disposable set successfully completed prime.As a result of the clot in the channel, blood spilled over into the plasma line.Additionally, the replacement line and collect recirc line are assembled in the wrong ports of the cassette.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported receiving continual return pump alarms during an exchange procedure on spectra optia.The return access was checked and no problems were noted.They noticed the replacement fluid line did not seem to connect with the replacement pump and saw blood backflowing to the albumin bottles.It is unknown at this time how much blood went into the albumin bottles.Patient information and outcome are not available at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in a.3, a.4, b.5, b.6, e.1 and h.10.Investigation: the run data file (rdf) was reviewed for this event.Based on the complaint description and the attached photos of the kit loaded on the device, it was confirmed that there was a manufacturing error that contributed to the issues experienced during this procedure.Review showed that the replacement fluid line and the plasma recirculation lines were switched at the cassette.When these lines are switched, the patient¿s red cells will b returned via the reservoir, plasma will be removed to the waste bag, however replacement fluid will not be returned to the patient.Testing has shown that this manufacturing defect can cause level sensor alarms during priming of the disposable kit.This defect will also cause fluid balance alarms to continually occur during the procedure as replacement fluid is not being returned to the reservoir, until a final fluid balance alarm will end the run.It is also possible that air may enter the reservoir from the replacement line in the absence of available fluid.Unfortunately, the starting run data file was unavailable for this procedure; only the rdf after the system was rebooted 9 minutes into the run was available.Review of the run data file after the procedure was rebooted did not show conclusive root cause for the reported issue but did confirm there was air in the reservoir that the operator tried to remove.This was evidenced in the available rdf as the air removal procedure was performed just before the procedure was ended.Investigation is in process.A follow up report will be provided.

Event Description

Patient gender and weight obtained from the run data file.

Event Description

Due to local australian regional regulatory restrictions, the customer could not provide the patient's identifier or age.No medical intervention was required for this event.

Manufacturer Narrative

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.Final patient fluid balance was determined to be within limits.Final fluid balance: 7010ml + 94ml (ac) ¿ 381ml (plasma removed) ¿ 185ml (no rinseback with exchange kit max ecv) = 6538ml/7010ml *100 = 93% the device history record was reviewed for this lot.There were no issues noted that would have contributed to the reported issue.Correction: manufacturing staff were made aware of this issue on 7/20/2020 and retrained to the appropriate procedures.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: per inspection of the photographs provided, blood was confirmed in the plasma line, the replacement line and in the drip chamber of the replacement line.The replacement line was completely void of fluid and the albumin bottle was completely full.The absence of rbcs in the rbc recirculation line indicates the channel rbc line was clotted off.Solvent occlusion is ruled out because the disposable set successfully completed prime.As a result of the clots in the channel, blood spilled over into the plasma line.Due to the switched lines, the channel contents in the plasma line were able to enter the replacement port above the cassette, and subsequently, into the replacement bottle.Root cause: based on the complaint description and the attached photos of the set loaded on the device, it was confirmed that there was a manufacturing error that contributed to the issues experienced during this procedure.Review showed that the replacement fluid line and the plasma recirculation lines were switched at the cassette ports.When these lines are switched, the patient¿s red cells will be returned via the reservoir and plasma will be removed to the waste bag; however, replacement fluid will not be returned to the patient.Testing has shown that this manufacturing defect can cause level sensor alarms during priming of the disposable set.This defect will also cause fluid balance alarms to continually occur during the procedure as replacement fluid is not being returned to the reservoir, until a final fluid balance alarm will end the run.It is also possible that air may enter the reservoir from the replacement line in the absence of available fluid.Unfortunately, the starting run data file (rdf) was unavailable for this procedure; only the rdf after the system was rebooted 9 minutes into the run was available.Review of the run data file after the procedure was rebooted did not show conclusive root cause for the reported issue but did confirm there was air in the reservoir that the operator tried to remove.This was evidenced in the available rdf as the air removal procedure was performed just before the procedure was ended.A definitive root cause for the clotting in the channel could not be determined.Potential causes include but are not limited to: the inlet/anti-coagulant ratios used in the procedure were inadequate to keep the extracorporeal circuit properly anti-coagulated, resulting in the activation of platelets.Activation of platelets as a result of the patient's physiology.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10017606
• MDR Text Key: 190182669
• Report Number: 1722028-2020-00198
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/01/2020

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: 01/01/2022
• Device Catalogue Number: 12220
• Device Lot Number: 2001023230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/09/2020
• Initial Date FDA Received: 05/01/2020
• Supplement Dates Manufacturer Received: 06/11/2020; 07/20/2020; 08/03/2020
• Supplement Dates FDA Received: 06/17/2020; 07/30/2020; 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 140