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

Model Number 12320

Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993); Pressure Problem (3012)

Patient Problem Reaction (2414)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Investigation: 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 ususally well tolerated.Symptoms often show as parasethesia (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.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable history search confirmed there were no similar occurrences of this issue reported on this lot worldwide.Terumo bct clinical support explained to the customer that the system was clotted.The machine needs to have enough flow coming from the patient into the system.The problem was the inlet/return pressures alarms causing the set to clot.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that 5 minutes into a continuous mononuclear cell (cmnc) collection on a spectra optia device, the patient had a citrate reaction and dizziness.The patient was given a 500 ml bolus of saline and 25 ml calcium chloride via iv per protocol.After the patient was stabilized from the citrate reaction, the collection was restarted.One hour into the collection, the operator was not able to bring any blood into the centrifuge due to inlet pressure low alarms and return pressure low alarms.The operator had many inlet pressure low alarms from the beginning of the collection.They were not able to perform rinseback.Per protocol the operator administered 500 ml (bolus) of saline.Per the customer, the patient was reported in stable condition.The customer declined to provide patient identifier and age.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the customer provided a picture of the end of run screen summary report.The screen confirmed that the 226 min procedure was terminated early after 69 minutes.Total blood volume processed was 0.9, the amount of ac to the patient was 309 ml and the patient tbv was 3858ml.There was no rinseback.The ac end of run summary report indicated the amount of ac to patient was 309ml and the patient tbv was 3858ml.The dizziness the customer described is more consistent with vasovagal reaction because the onset of the symptoms occurred 5 minutes into the procedure where the patient had received a very small amount of ac.The device was being operated in caution status due to the ac infusion rate of 1.4ml/min.This change was made well after the alleged reaction.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged vasovagal reaction include but are not limited to patient disease state and/or patient sensitivity to the procedure.A definitive root cause for the access alarms could not be determined.Possible causes include but are not limited to: patient physiology/poor venous access.Patient access was not properly positioned by the operator the possible causes above can result in reduced inlet flow leading to clotting in the set, which ultimately ended the procedure.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10727318
• MDR Text Key: 213014423
• Report Number: 1722028-2020-00483
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 2006193330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 70