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

Catalog Number 000000000000070500

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem Hemolysis (1886)

Event Date 11/06/2014

Event Type  Injury  

Manufacturer Narrative

Investigation: per the customer, the replacement fluids attached were 0.9% normal saline, acda, and 5% albumin.Lab samples confirmed the presence of hemolysis.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a patient was undergoing a therapeutic plasma exchange (tpe) procedure.At the beginning of the procedure, they received multiple 'plasma line contamination detected' alarms and observed red cells in the waste bag.They could not see a clear separation of cells in the channel.The operator ended the procedure and disconnected the patient.Further lab tests were done to check for hemolysis.The patient was set up on another machine with a new disposable set to complete the procedure.Slight hemolysis was noted again.The attending physician ok'd the continuation of the procedure.The customer declined to provide the patient identifier.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to the potential for injury if the same failure were to reoccur.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to hemolysis in the waste bag.A service call was placed for the machine.The machine operated according to manufacture's specifications and no issues were found that was related to hemolysis.During follow up with the customer, they confirmed that the patient has hemolysis, but stated they weren't sure of the cause.Root cause: the disposable set was not returned for investigation.A service call was placed for the machine and no issues were found.Root cause for hemolysis is likely related to the patient disease state since the customer reported that slight hemolysis continued into the second procedure despite a different machine and disposable set used.Additionally, the customer reported seeing red cells immediately at the start of the procedure and customer stated that the patient has hemolysis in a follow up call.

Event Description

The patient is in stable condition.

Manufacturer Narrative

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

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.

• 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: 4267078
• MDR Text Key: 15953896
• Report Number: 1722028-2014-00472
• 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,Followup,Followup
• Report Date: 11/06/2014

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: 08/01/2017
• Device Catalogue Number: 000000000000070500
• Device Lot Number: 08W15230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 11/20/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/07/2015; 01/23/2015; 02/06/2015; 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2014
• 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
• Patient Age: 00062 YR
• Patient Weight: 91