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 Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 10/27/2014

Event Type  Injury  

Event Description

The customer reported, a patient had allergic reactions during therapeutic plasma exchange(tpe) procedures.The first procedure had to stop in less than 20 minutes due to throat tightness.The second procedure stopped at 80% due to rash, hives, and the patient stating they were feeling bad.The third procedure went to completion but the patient still had a rash.Solumedrol, benadryl, pepcid and tylenol was dispensed before and after the procedures.The patient is an inpatient and remains in icu.The patient is in stable condition.The disposable kit is not available for investigation, because the customer discarded it.This report is being filed due to medical intervention via solumedro, benadryl, pepcid and tylenol administered before and after the event.

Manufacturer Narrative

Investigation: the customer primed the set two times on the second procedure and they primed it three times on the third procedure.The cobe spectra aphersis system essentials guide outlines possible adverse effects with the following information: "be aware of possible donor or patient reactions during apheresis procedures."a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: this disposable set was unavailable for specific root cause analysis.A definitive root cause could not be determined.Based on customer statements, it is possible that the reaction is due to patient physiology and possible allergies to eto, albumin, or acd-a, or possible medication interactions with acd-a or albumin.

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 in the mdr form.This supplement is being filed to modify information in to align with the reported event.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA TPE SET
• Manufacturer (Section D): TERUMO BCT; CO 80215
• Manufacturer Contact: robbin crafe ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392282
• MDR Report Key: 4256548
• MDR Text Key: 5015653
• Report Number: 1722028-2014-00466
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK020041
• 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: 10/31/2014

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 Expiration Date: 01/01/2017
• Device Catalogue Number: 000000000000070500
• Device Lot Number: 01W15272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 11/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2014
• 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; Required Intervention
• Patient Age: 00047 YR
• Patient Weight: 60