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

Catalog Number 000000000000070500

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

Patient Problems Stacking Breaths (1593); Anaphylactic Shock (1703); Skin Irritation (2076)

Event Date 03/17/2014

Event Type  Injury  

Event Description

The customer reported that a patient had an anaphylactic reaction to the fresh frozen plasma(ffp) during a therapeutic plasma exchange (tpe) procedure.40 minutes into the procedure,the patient complained of shortness of breath and hives.The nurse disconnected the patient and the physician ordered iv benadryl in response to the patient reaction.Per the customer,the patient remained hospitalized following the event and is in stable condition.Customer declined to provide patient's identifier, age, and weight.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to medical intervention in the form of iv benadryl.

Manufacturer Narrative

Investigation: the disposable set was unavailable for return and 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.A service call was placed and the machine was inspected.The machine was verified to be working as designed.Root cause: the kit was unavailable for specific root cause.The machine was evaluated and determined to be functioning as intended.Based on the spectra optia system functioning as intended and the customer's evaluation of the issue, the reaction was due to the patient's physiology.Per the therapeutic apheresis handbook: a physician's reference, 2nd edition, plasma replacement reactions may occur in approximately 7.8% of procedures, based on the results of a survey of therapeutic procedures.Of these reactions, most were mild and well tolerated.The spectra system has many safety features.A patient reaction can occur rapidly, however, it is imperative that the operator continuously monitor the spectra system and the patient.The spectra essentials guide contains further cautions and warnings for the user.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated appropriately.This supplement is being filed to modify information to align with the reported event.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA TPE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3754464
• MDR Text Key: 4415673
• Report Number: 1722028-2014-00122
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K831004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2014

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: 000000000000070500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2014
• Initial Date FDA Received: 04/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2016
• 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): Required Intervention