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

Catalog Number 10220

Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

Investigation: calcium gluconate 3gm ivpb in 150 ns was administered as a part of the protocol for treatment.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported a 'patient's fluid balance may be 15% lower than reported' alarm during a therapeutic plasma exchange (tpe) procedure on a r/o guilliane-barre patient.She was not able to continue with the procedure.The procedure was paused because the patient blood pressure (bp) had gone up and they had to treat her with medication (hydralzine 10 mg ivp).The machine was paused approximately 20 min.When she tried to restart there were reservoir & return alarms that lead to adjusting volume in reservoir.Then there were fluid balance alarms.She saw clumping in the reservoir filter.The operator attempted to rinseback the patient and it only rinsed back for about 1 min.The final rinse back volume was 57 ml.Fluid balance calculated by machine 98%; (-) 88 mls.The calculated fluid balance was +152 mls (this includes calcium).The patient was stable following the procedure.The customer declined to provide patient identifier.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 h.6 and h.10.Investigation: a disposable history search was performed for this lot.No additional reports of a similar issue were found.The device history report (dhr) was reviewed for this lot.There were no issues noted that would have contributed to the alleged patient reaction as experienced by the customer.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the increase in bp include but are not limited to patient disease state and/or patient sensitivity to the procedure.The cause of the fluid balance alarm was due to the clumping observed in the reservoir.A definitive root cause for the clumping could not be determined.Possible 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, EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10138382
• MDR Text Key: 195585617
• Report Number: 1722028-2020-00286
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: 10220
• Device Lot Number: 2003093230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00020 YR
• Patient Weight: 102