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

Catalog Number 10120

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Tingling (2171); Discomfort (2330); Reaction (2414); No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that a bone marrow transplant (bmt) patient was undergoing an autologous continuous mono nuclear cell (cmnc ) collection procedure.After processing approximately 4.5 of 5l requested by the physician, the patient experienced general discomfort with tingling sensation in her hands and legs and had sphincter relaxation.Per physician's order,the procedure was stopped immediately and the donor was disconnected without rinse back.The patient was administered calcium gluconate to manage the symptoms.After the vital signs were restored, the patient was hospitalized in medullary transplant unit for further monitoring and continued with the planned reinfusion of the cells collected for her bone marrow transplant (bmt) procedure.The customer stated that patient is hospitalized due to her bmt, but has recovered and is reported in stable condition.Patient identifier and weight are not available at this time.The cmnc set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: per the therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcaemia associated with apheresis is usually well tolerated.Symptoms often show as paraesthesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcaemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcaemia escalates and is not corrected.We have verified that no safety issue has occurred, nor was a safety issue reported as a result of this incident.Based on the information provided by the customer, the patient was hospitalized for monitoring prior to planned bmt.

Manufacturer Narrative

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

Event Description

During follow-up with the customer, it was confirmed that the patient did not suffer an injury as a result of this event.

Manufacturer Narrative

This report is being filed to provide additional information.

Manufacturer Narrative

This report is being filed to provide additional information and clarification of the event and a correction to indicate serious injury (patient reaction requiring medical intervention) that was marked as malfunction in sup 2 and sup 3.Investigation: the disposable set was not available for return for investigation.The run data file (rdf) was analyzed for this event.There were no signals in the rdf that would indicate the machine did not operate as intended.The system was operating within the safety limits programmed in the machine.The device was found to be operating as intended, and within the generally tolerated limits for the majority of patients.There was no system or device malfunction identified that would indicate an issue with the optia system.The optia system appeared to be operating as intended and is safe to use.The device history record (dhr) was reviewed for this lot.There are no issues identified in the dhr that would have contributed to this event.Root cause: based on the risk assessment, clinical findings, and investigation, the root cause of the patient reaction and need for medical intervention (calcium gluconate infusion) for the patient reaction is inconclusive.Possible causes for the patient reaction include but are not limited to the patient's disease state and/or sensitivity to the procedure.

Event Description

Clarification: while the patient did not suffer a lasting or permanent injury as a result of the collection procedure, the patient did require medical intervention in the form of calcium gluconate infusion to counter the effects of the reaction during the procedure.Hospitalization of the patient was not in response to or used to treat the patient reaction, but was part of the overall planned treatment of the patient disease state.

Manufacturer Narrative

This report is being filed to provide additional information.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
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7525970
• MDR Text Key: 108669612
• Report Number: 1722028-2018-00136
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/18/2018

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: 03/01/2019
• Device Catalogue Number: 10120
• Device Lot Number: 03A3210
• Other Device ID Number: 05020583101203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 07/25/2018; 07/27/2018; 08/29/2018; 10/26/2018; 10/26/2018
• Supplement Dates FDA Received: 07/27/2018; 08/21/2018; 09/14/2018; 10/30/2018; 10/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2017
• 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: 00055 YR
• Patient Weight: 56