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

Model Number 10120

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

Patient Problems Tachycardia (2095); Chills (2191); Reaction (2414)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

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 and there were no issues during the procedure.The following alarms occurred during the procedure: 1x return pressure was too high when system was diverting saline 1x return pressure was too high.1x interface took too long to establish access alarms alone are not known to cause adverse events but the excessive occurrence of them points toward issues with the patient access.The constant alarming of the device combined with frequent manipulation of the access may have caused increased agitation in the patient and resulted in the adverse event for some of these procedures.The most common source of inlet pressure alarms is when the inlet flow rate is set too high for the given patient access, the patient access is occluded/blocked, or the patient access is not properly positioned.In response to inlet pressure alarms, it is suggested to ensure the patient access is appropriately sized and positioned, nothing is blocking the access line, and to lower the inlet flow rate.Throughout the procedure the ac was returned at 0.9ml/min/ltbv to the patient.No other potential sources of a patient reaction were identified.The system operated as intended and the procedure was run within standard operating limits (i.E.Not in ¿caution status¿).Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that an autologous patient with non-hodgkin¿s lymphoma experienced a reaction during a collection procedure.The patient presented chills, nausea, restlessness, headache, biliary vomit, hyperthermia (temperature increase from 37 to 39 degrees celsius), and tachycardia of 131 beats per minute.There were no signs of muscle spasms, chvostek signs, signs of trousseau, tetany, arrhythmia, or seizure.Two ampules with 1 gram each of calcium gluconate were administered.Hydrocortisone was also administered.The patient's symptoms reversed after three hours.Patient identifier and age are not available at this time.The disposable set is not available for return because it was discarded by the customer.

Event Description

Patient identifier and age are not available from the customer.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6, and h.10.Corrected information is provided in b.6.Root cause: no definitive root cause for the reported adverse events could be identified from the dlogs associated with these procedures.The system operated as intended and the procedures were run within standard operating limits (i.E.Not in ¿caution status¿).The procedure on (b)(6) had 64 ¿inlet pressure was too low¿ alarms and 24 ¿return pressure was too high¿ alarms.353ml of ac was delivered to the patient over the course of the procedure.Access alarms alone are not known to cause adverse events but the excessive occurrence of them points toward issues with the patient access.The constant alarming of the device combined with frequent manipulation of the access may have caused increased agitation in the patient and resulted in the adverse event for some of these procedures.The most common source of inlet pressure alarms is when the inlet flow rate is set too high for the given patient access, the patient access is occluded/blocked, or the patient access is not properly positioned.In response to inlet pressure alarms, it is suggested to ensure the patient access is appropriately sized and positioned, nothing is blocking the access line, and to lower the inlet flow rate.Throughout the procedures the ac was returned at 0.9ml/min/ltbv to the patients during the four mnc procedures and 1.2ml/min/ltbv for the one cmnc procedure.No other potential sources of a patient reaction were identified.In summary, a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged citrate reaction include but are not limited to patient disease state and/or patient sensitivity to anticoagulant.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: a disposable search history was performed for this lot.There were 2 other similarly reported incidents on this lot from the same customer in the same incident month.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the patient reaction as experienced by the customer.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide corrected information in h.10.Updated root cause: no definitive root cause for the reported adverse event could be identified from the dlog 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 procedure on (b)(6) had 2 ¿return pressure was too high¿ alarms.607ml of ac was delivered to the patient over the course of the procedure.Throughout the procedure the ac was returned at 0.9ml/min/ltbv to the patient during the mnc procedure.No other potential sources of a patient reaction were identified.In summary, a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged citrate reaction include but are not limited to patient disease state and/or patient sensitivity to anticoagulant.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: 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 ususally well tolerated.Symptoms often show as parasethesia (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.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9739265
• MDR Text Key: 188347567
• Report Number: 1722028-2020-00068
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583101203
• UDI-Public: 05020583101203
• 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,Followup,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: 10120
• Device Catalogue Number: 10120
• Device Lot Number: 1905093331
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 68