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

Model Number 10310

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

Patient Problems Fever (1858); Reaction (2414)

Event Date 10/19/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that after 1.5 total blood volume (tbv) was processed on a spectra optia device, a pediatric patient started shivering and had a high grade fever.Per the customer's medical officer the patient was given iv calcium gluconate, injection avil, injection hydrocot and injection merowin.Per the customer the patient is reported as "recovered stable".The patient identifier is not available from the customer.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in investigation: 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: 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.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: the optia essentials guide advises the operator of possible adverse effects of apheresis procedures and to be prepared to take appropriate action should any reactions occur.Some previously reported reactions are: anxiety, headache, light-headedness, digit and/or facial paresthesia, fever, chills, hematoma, hyperventilation, nausea and vomiting, syncope (fainting), urticaria, hypotension, and allergic reactions.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.6, h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Root cause: no definitive root cause for the reported adverse patient reactions could be identified from the rdf associated with this procedure.It is important to monitor the connector and collect port for clumping especially if the run has been paused for more than 3 minutes due to alarms or patient issues.At 114 minutes into the run, the pumps were paused for over 3 minutes which was evidenced by large variations seen in the rg ratio signals afterwards when the run resumed.This may occur if there was clumping and/or could be related to patient blood physiology.If clumping is identified or suspected, it is recommended to decrease the ratio to 8 and leave it there until the clumping has resolved.In summary, 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.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9310335
• MDR Text Key: 166177156
• Report Number: 1722028-2019-00341
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• 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 Model Number: 10310
• Device Catalogue Number: 10310
• Device Lot Number: 1903063131
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00014 YR
• Patient Weight: 58