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

Catalog Number 70500

Device Problems Coagulation in Device or Device Ingredient (1096); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer reported that the replacement fluid was 5% albumin in bags from the manufacturer.Saline and acd-a were used in the correct place.Only a complete blood count (cbc) and basic metabolic testing (bmp) tests were ordered.No hemolysis testing was performed.No clotting was observed and custom prime was not performed.Per the customer, this machine last had a preventative maintenance (pm) performed on 01/29/2019 by bio-med at the site.Investigation is in process.A follow-up report will be provided.

Event Description

The customer report that approximately three quarters of the way of the way through a therapeutic plasma exchange (tpe) procedure on a patient with myasthenia gravis (mg), the operator noticed hemolysis in the plasma line as it exits the centrifuge to the waste bag.The customer contacted tbct customer support and was advised to check the interface.Per the operator, she could see the difference between the red cells and the plasma earlier, but the plasma was pink tinged for the current check.The operator was advised by tbct customer support to contact the physician at the customer site to discuss if the patient condition was related and if the procedure should be continued.The customer site nephrologist decided not to continue the procedure and rinseback was not performed.Per the operator, the plasma was a yellow color earlier in the procedure and for the other two procedures performed for this patient.The patient is reported in stable condition and is doing "well", no medical intervention was required for this event.No further apheresis treatments have been requested as this was the third of three planned for this patient.The customer declined to provide patient id.The cobe spectra tpe collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide in investigation: a review of the device history record (dhr) for this unit showed no irregularitiesduring manufacturing that were relevant to this issue.Root cause: a definitive root cause of the reported hemolysis could not be determined.Possible causes include, but are not limited to:- an unidentified pinched or kinked line in the disposable set- patient's disease state.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA TPE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8855025
• MDR Text Key: 165018984
• Report Number: 1722028-2019-00211
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Catalogue Number: 70500
• Device Lot Number: 01B15264
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 08/21/2019
• Supplement Dates FDA Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00022 YR
• Patient Weight: 64