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

Catalog Number 12220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Numbness (2415)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: a disposables history search confirmed there were no similar occurrences reported on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as paresthesia (tingling), but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.Reductions of ionized calcium seen in apheresis can also lengthen the plateau phase of myocardial depolarization, thereby leading to prolongation of the qt interval in the electrocardiogram (ekg).Any arrhythmias and qrs widening are detectable entities that may be signs of clinically significant reductions in ionized calcium.Testing stat ionized calcium levels before and during the procedure will enable the clinician to correlate patient signs and symptoms which the calcium level to monitor response to calcium infusion and to tailor further treatments.The run data files were analyzed for this event.From the files, the pumps and sensors performed according to specification.There were no abnormal alarms that would have been detrimental to the procedure or the patient.The ac infusion rate used throughout the procedure was well within the limits tolerated by most patients.Pressures and levels in the set were within the normal operating ranges.The device performed according to our design and specifications.A terumo bct service technician checked out the device at the customer site, preventative maintenance and full system auto test were successfully completed.The device met manufactures specifications.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged citrate reaction include but are not limited to ac management during the procedure, patient disease state, and/or patient sensitivity to anticoagulant.

Event Description

The customer reported that the patient complained of chest tightness, numbness and tingling 1 hour 15 minutes into a red blood cell exchange (rbcx) procedure using a spectra optia device.The patient received iv calcium gluconate 1gm pb in 50ml normal saline, tums 1gm x2 and dilaudid 2mg iv during the procedure.The customers physician ordered an ekg during the procedure, sinus rhythm and prolonged qt interval.Per the customer the patient's providers approved to continue the apheresis.The patient has since been discharged from the er.The customer confirmed the device was not being operated in caution status.Prior to the procedure the patient presented with abdominal pain 5 out of 10.The patient felt tired and achy.The patient received 25mg oral benadryl.The disposable set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 11553813
• MDR Text Key: 242670800
• Report Number: 1722028-2021-00124
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 12220
• Device Lot Number: 2009303230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• 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: 00032 YR
• Patient Weight: 54