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 Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Increased Respiratory Rate (2486)

Event Date 11/07/2014

Event Type  Death  

Event Description

The customer reported that just after starting a therapeutic plasma exchange (tpe) procedure on a ventilated icu patient, the patient's heart rate decreased and respiratory rate increased.The icu nurse called a code and the apheresis nurse disconnected the patient from the tpe.Cpr and medication were given in attempts to resuscitate the patient, but the patient expired after multiple attempts.Per the customer, patient's condition was the cause of the cardiac arrest and the patient's incident is not alleged to be related to the apheresis machine or the disposable apheresis set used during the procedure.Patient's identifier is not available at this time.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to patient death, although at this time it is not alleged or suspected that the device was a contributory factor.

Manufacturer Narrative

Investigation: per the customer, the icu nurse was concerned about rhythm and ekg changes prior to the connection to the apheresis machine.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to the death of the patient.The apheresis nurse indicated that the patient expired approx 1-2 minutes after being connected to the machine for treatment.The procedure was in the prime/divert phase.Additional patient condition details were requested, but not provided by the customer.Root cause: the disposable set was unavailable for investigation.Based on the patient's significant medical history, and the icu nurses concern over the patient's unexpected rhythm and ekg changes prior to starting the procedure.The root cause of the patient's death, was due to the patient's medical condition.

Event Description

The customer declined to provide the patient's identifier.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which ane vent occurred, but the type of reportable event was not indicated appropriately in the mdr form.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: 4291392
• MDR Text Key: 5271106
• Report Number: 1722028-2014-00475
• 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,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Catalogue Number: 000000000000070500
• Device Lot Number: 07W15275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 12/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/30/2015; 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2014
• 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 Age: 00055 YR
• Patient Weight: 82