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

Catalog Number 70700

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Fever (1858); Staphylococcus Aureus (2058)

Event Date 02/22/2016

Event Type  Injury  

Manufacturer Narrative

Investigation: per the customer, during the rbcx, the patient's mother had stated that the patient wasn't her usual self and was exhausted.She also stated that the patient had flu like symptoms a few days before.Per the customer, the patient's temperature increased from 36.7 degree celsius to 38.2 degree celsius during the procedure.Internal investigation is in process a the hospital and the mobile apheresis unit.The customer stated that the patient is having the vortex port removed.Per the customer, there were two incidents of line contamination at this hospital associated with this lot.The other incident has been reported on mdr # 1722028-2016-00147.There are no other similar reports associated with this lot number.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the hospital to which they provide apheresis units had a patient with a line infection (right chest vertex port) by a bacteria, staph aureus.The patient underwent a red blood cell exchange (rbcx) procedure with 996mls of packed rbcs.The units were associated with lot # 08y15237.The evening after the rbcx procedure, the patient presented to the er with a fever.Per physician's order, the patient was given 5 days of antibiotics.The patient is reported in stable condition currently.The customer declined to provide the patient's identifier and weight.The disposable kit is not available for return, because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation is in progress.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide corrected incident date and additional information.Investigation: a review of the device history record for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in progress.A follow-up report will be provided.

Manufacturer Narrative

The customer stated that the bacterial strain is staph aureus.Based on literature review, staph aurerus is a bacteria that is frequently found on the skin.S.Aureus is observed in severe transfusion reactions, which are thought to be the result of inadequate skin disinfection or transient bacteremia of the donor at the time of donation.The devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level(sal) of

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA RED BLOOD CELL EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5529390
• MDR Text Key: 41266091
• Report Number: 1722028-2016-00148
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 70700
• Device Lot Number: 08Y15237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2015
• 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; Required Intervention
• Patient Age: 00017 DA
• Patient Weight: 69