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 Tachycardia (2095); Reaction (2414)

Event Date 08/16/2019

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, chills with raised bp.The donor also had tachycardia with heart beat rate at 110/min.Per physician's order, the donor was administered calcium gluconate (iv), avil (iv), hydrocortisone 100mg (iv) intravenously and paracetamol tablet 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.Full donor identifier (id) : (b)(6).The spectra optia idl set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide in 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 for the reported adverse events 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¿).The customer submitted a photo of the donor's pretransfusion workup and gcsf schedule prior to the pbsc procedure.No abnormalities were noted.Root cause: based on the clinical findings and run data analysis, a definitive root cause for the donor's reaction could not be determined.Possible causes include, but are not limited to ac management during the procedure and/or donor sensitivity to anticoagulant.- attachment: [re_ new hp complaint for india 8_29_2019.Msg].

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9098587
• MDR Text Key: 163917827
• Report Number: 1722028-2019-00274
• 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

• 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
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/20/2019
• Supplement Dates Manufacturer Received: 10/04/2019; 11/26/2019
• Supplement Dates FDA Received: 10/15/2019; 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00047 YR
• Patient Weight: 97