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

Catalog Number 10310

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Nausea (1970); Dizziness (2194); Reaction (2414)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

Investigation: a terumo bct service technician inspected the machine at the customer site and performed a system checkout.An autotest and a saline run were successfully performed to verify the functionality of the machine.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a patient experienced a reaction, including nausea and dizziness, at the beginning of the procedure on spectra optia.Per physician order, the patient received 8 mg of zofran and 10 mg of compazine intravenously in response to the reaction.The patient is reported in stable condition.The customer declined to provide patient's identifier (id).The spectra optia idl set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: per rdf review, the system was operating within the safety limits for fluid balance.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 reference, adverse events occur during therapeutic procedures has a frequency of 4.8%.Vasovagal incidents occur around 0.5% of procedures.The reactions generally manifest as pallor and diaphoresis.In a full blown attack, the reaction progresses from pallor and sweating to pulse slowing and blood pressure decreasing.More severe vasovagal reactions may include nausea, vomiting, and/or convulsions.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 patient disease state and/or patient sensitivity to the procedure.

• 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: 7584166
• MDR Text Key: 110592453
• Report Number: 1722028-2018-00163
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172590
• 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
• Report Date: 06/08/2018

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: 03/01/2020
• Device Catalogue Number: 10310
• Device Lot Number: 1803193330
• 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
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/08/2018
• Supplement Dates Manufacturer Received: 10/19/2018
• Supplement Dates FDA Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2018
• 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): Required Intervention
• Patient Age: 00062 YR
• Patient Weight: 86