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

Catalog Number 10310

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 01/01/2008

Event Type  Injury  

Manufacturer Narrative

Investigation: the customer initially contacted terumo bct for recommendation onacda/heparin protocol on patients with amyloidosis while collecting stem cells on optia.Per the customer, current procedure for cmnc procedures on patients with amyloidosis is using a10% of 750 units of heparin/acd-a with ratio of 750 units of heparin in 750 ml of acd-a.Current procedure at the customer site is starting a cmnc procedure that runs approximately for 3.5 hrs with the transfusion of 2 gm of cacl first, and if the ionized calcium level measured to be low during the procedure,the patient is given a 1 gm of more cacl.The customer further mentioned that they had a policy to use an ac ratio of 20:1 going to a maximum of 25:1 and to add 15 ml of 10% heparin/acd-a to the product bag at the start of the collection.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that during a stem cell collection procedure an amyloidosis patient experienced a reaction.Per customer, the patient's ionized calcium level got too low due to the usage of anticoagulant citrate dextrose solution, solution a (acda) and patient's heart could not compensate.It is unknown at this time if medical intervention was required for this event.Patient information is not available at this time.Patient outcome is not available at this time.The spectra optia idl set is not available for return because it was discarded by the customer.

Manufacturer Narrative

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

Manufacturer Narrative

This report is being filed to provide corrected information and additional information.Investigation: the disposable set was not available for return.Lot number could not be provided by the customer, therefore, a device history record review could not be performed.All lots must meet acceptance criteria for release.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.The handbook also states, that reductions of ionized calcium seen in apheresis can also lengthen the plateau phase of myocardial depolarization.Management of citrate toxicity during apheresis is straight forward in most cases.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged 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 a patient reaction that had happened prior to 2009.This event was mentioned in (b)(6) 2018 during a conversation about heparin/acda protocols.Due to elapsed time since the event, per the customer, event details such as event date, patient information, patient status and whether or not any medical intervention was necessary could not be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7560405
• MDR Text Key: 109773476
• Report Number: 1722028-2018-00150
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10310
• Other Device ID Number: 05020583103108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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