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

Catalog Number 70610

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Reaction (2414); Numbness (2415)

Event Date 11/05/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An article in 'transfusion and apheresis science', november 2015, documented a retrospective analysis of peripheral blood stem cell (pbsc) collections performed march 2010 - december 2013.Of the collections that were analyzed, there were 63 occurrences of patients suffering from hypocalcemia during the pbsc collections on cobe spectra.The symptoms included perioral paresthesia followed by digital numbness.It is not known at this time if medical intervention was required for the patient reactions.Forty of the 63 patients had been injected with a 5-10ml bolus of 10% calcium gluconate during the procedure as part of the study.Twenty three of the 63 patients had continuous 10% calcium gluconate infused during the procedure as part of the study.Patient information is not available at this time.This report is being filed for one of the 63 patients.Exact details of each patient reaction are not available at this time.The disposable set is not available for return because it was discarded by the customer.The title of the article is 'prophylactic low dose continuous calcium infusion during peripheral blood stem cell (pbsc) collections to reduce citrate related toxicity.'.

Manufacturer Narrative

Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury based on additional investigational information.The physician in charge, and co-author of the study, confirmed that there was no medical intervention required for the patient reaction.According to the aabb therapeutic apheresis: a physicians handbook, the rate of adverse events during therapeutic apheresis is 4-5%.A specific device history record review could not be performed due to lack of lot information, however, all lots must meet acceptance criteria for release.Root cause: the disposable set was unavailable for return.The study acknowledges that the patient reaction was due to citrate toxicity and understands this is a frequent complication of apheresis procedures.

Event Description

Per the customer, no medical intervention was required for this event.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA AUTOPBSC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w. collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5563992
• MDR Text Key: 42374930
• Report Number: 1722028-2016-00204
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 70610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• 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