MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA BLOOD COLLECTION; COBE SPECTRA WHITE BLOOD CELL SET

Catalog Number 70600

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

Patient Problems Seizures (2063); Test Result (2695)

Event Date 01/01/2006

Event Type  Injury  

Manufacturer Narrative

Article: bachier, carlos, et.Al.(2012).High white blood cell concentration in the peripheral blood stemcell product can induce seizures during infusion of autologous peripheral blood stem cells.Biology of blood and marrow transplantation, 18, 1055-1060.Investigation is in progress.A follow-up report will be provided.

Event Description

During a review of an article in the journal, biology of blood and marrow transplantation,terumo bct became aware of an adverse event that occurred upon infusion of autologous peripheral blood stem cells (pbsc).The patient had pbsc collected on cobe spectra, and upon infusion, experienced a seizure.It is unknown at this time if medical intervention was necessary for the event.The white blood cell count of the pbsc product was at or above 590x10^3,per the article the patient was reported to be fully recovered after a postictal state with no further neurologic recurrence.The patient information, outcome, and procedure details are unknown at this time.The incident date is unknown at this time, but the study stated the dates were between january 2006 and july 2009.The disposable kit is not available for return, because it was discarded by the customer.

Manufacturer Narrative

Investigation: the journal article itself states : "seizures as a complication of the autologous peripheral blood stem cells (pbsc) are rare" and complications during infusion of thawed autologous stem cells are mostly related to side effects of dimethyl sulfoxide (dmso), and volume infused at the time of infusion.The etiology of seizures in these patients is poorly understood."per the article, with the intent of evaluating a causative factor for the seizures, patients underwent imaging studies, electroencephalogram, cerebrospinal fluid analysis, electrolyte analysis,arterial blood gas analysis, and evaluation of medication history; no causative factors were found.The handbook for therapeutic apheresis states the overall incidence of transfusion reactions has a frequency of 1.6%.Furthermore, severity is greater in acutely ill patients.The customer was unable to provide a lot number for the collection set or a serial number for the machine used, therefore a device history record review could not be performed for the collection set lot.All lots must meet acceptance criteria for release.A checkout of the machine could also not be performed.Root cause: root cause of the patient reaction remains undetermined at this time.Possible causes include but are not limited to:- sensitivity to dmso- patient physiology.

Event Description

Per the customer, the patient data for this incident is unavailable.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: per the article, all patients fully recovered with no further neurological sequel.Per terumo bct's medical review, the device did not cause or contribute to this incident.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA WHITE BLOOD CELL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5733399
• MDR Text Key: 47706155
• Report Number: 1722028-2016-00385
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2016

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 Catalogue Number: 70600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2016
• Initial Date FDA Received: 06/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/05/2016; 10/07/2016
• 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