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

Catalog Number 10310

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

Patient Problems Anaphylactic Shock (1703); Tachycardia (2095); Reaction (2414)

Event Date 08/24/2019

Event Type  Injury  

Manufacturer Narrative

Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that while undergoing continous mononuclear cell (cmnc) collection on spectra optia the gcsf mobilized donor experienced intense shivering, raised bp and fever.The donor also had tachycardia with heart beat rate at 110/min.Per physician's order, donor was administered i/v calcium gluconate, i/v avil, i/v paracetamol and i/v hydrocortisone 100 mg to manage the symptoms caused as a result of a reaction.Per the customer, the donor is reported as 'recovered' and in the stable condition.The exact incident date for this specific event is not known at this time.Donor identifier (id) : (b)(6).The spectra optia idl set is not available for return because it was discarded by the customer.

Event Description

The exact incident date for this specific event is reported accurately in the initial report.

Manufacturer Narrative

This report is being filed to provide in.Investigation: a review of the device history record (dhr) for this unit showed no irregularitiesduring manufacturing that were relevant to this issue.According to therapeutic apheresis: a physician's handbook, adverse events occur duringtherapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated withapheresis is ususally well tolerated.Symptoms often show as parasethesia (tingling) but patientsmay also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severehypocalcemia may also cause muscle contractions and can progress to tetany and seizures ifhypocalcemia escalates and is not corrected.Investigation is in-process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide in investigation: the run data file (rdf) was analyzed for this event.No definitive root cause forthe reported adverse event could be identified from the rdf associated with this procedure.The system operated as intended and the procedure was run within standard operating limits (i.E.Not in ¿caution status¿).There were 48 ¿inlet pressure was too low¿ alarms in the procedure it lasted from 10:31-17:53,that means the patient was connected for more than 7 hours.1268ml of ac was delivered tothe patient over the course of the procedure.Access alarms alone are not known to cause adverse events but the excessive occurrence ofthem points toward issues with the patient access.The most common source of inlet pressurealarms is when the inlet flow rate is set too high for the given patient access, the patient access isoccluded/blocked, or the patient access is not properly positioned.Throughout the procedure the ac was returned at 0.8ml/min/ltbv to the patients.Nopotential sources of a patient reaction were identified.Root cause: a definitive root cause for the donor's reaction could not be determined.Possiblecauses include, but are not limited to ac management for the donor's physiology during theprocedure, the length of the procedure, and/or the donor's sensitivity to anticoagulant.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9099349
• MDR Text Key: 163918336
• Report Number: 1722028-2019-00277
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: 10310
• Device Lot Number: 1903063131
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00031 YR
• Patient Weight: 92