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

Catalog Number 70500

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

Patient Problems Infiltration into Tissue (1931); Reaction (2414)

Event Date 11/20/2012

Event Type  Injury  

Manufacturer Narrative

Article:jeffrey l.Winters, edwin a.Burgstaler, jerome l.Gottschall, rasheed a.Balogun, jaime r.Houghton,wanda j.Lee, and edward l.Snyder (2013).A multicenter evaluation of a new therapeutic plasma exchange procedure.Transfusion, 53,hemapheresis, volume 53, december 2013 transfusion 3269-3278.Investigation is in progress.A follow-up report will be provided.

Event Description

During a review of an article in the journal transfusion, (volume 53, december 2013), terumo bct became aware of an adverse event reported as part of a study.Patients were undergoing therapeutic plasma exchanges (tpes), and one patient experienced an infiltration.The event was reported as mild severity, however, it is not known at this time if medical intervention was required for this event.Patient information, specific procedure date, procedure details and patient outcome are not known at this time.Article submission date was 11/20/2012.The disposable kit is not available for return, because it was discarded by the customer.

Manufacturer Narrative

Investigation: the customer did not provide the lot number pertaining to this event,therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Per the therapeutic apheresis handbook: a physician's reference, 2nd edition, first time procedure patients reactions may occur in approximately 6.9% of procedures with an overall adverse event rate of 4.8%.The 1.2% of procedure patients experience reactions to citrate, based on the results of a survey of therapeutic procedures.Of these reactions, most were mild and well tolerated.Additional information was obtained from the study's main author and he stated: "the reactions represented mild citrate toxicity unrelated to the apheresis device.These are common reactions seen with all apheresis devices related to the electrolyte disturbances coming from the use of citrate anticoagulant."root cause: because the disposables product was not available for return, no equipment serial numbers were provided in the journal article and the primary author of the article could not provide additional data about the adverse reactions during the study procedures the definitive root cause for the reactions cannot be determined.Possible cause of a citrate reaction (as specified by the study author for these occurrences) is that the donors were experiencing mild reactions due to decreased ionized calcium in circulation as a result of exogenous citrate administered during the apheresis procedures.These symptoms may be treated with oral or intravenous calcium supplements or by adjusting the acd infusion.

Event Description

Due to hippa regulations, the journal article author could not provide any additional information about the study participants or specific treatment for their reactions.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA TPE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5733073
• MDR Text Key: 47665906
• Report Number: 1722028-2016-00379
• 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
• 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: 70500
• 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
• Supplement Dates FDA Received: 08/05/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other