MAUDE Adverse Event Report: TERUMO BCT, LTD TERUFLEX BLOOD BAG SYSTEM; TRIPLE TB CPD/AS-5 350ML ENG

Catalog Number 3BO356E8

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Patient Involvement (2645)

Event Date 02/24/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer reported that the blood bag was centrifuged at speed of 3320rpm within 13 minutes by a centrifuge kubota 9942.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that after centrifuging, the plasma component had red color due tot he rupture of the red blood cells (rbc).There was not a transfusion recipient or patient involved at the time of whole blood processing, therefore no patient information is reasonably known at the time of the event.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.The teruflex blood bag set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide corrected information.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The testing records of the reported lot were reviewed and it was confirmed that all testing results passed and met the testing criteria.Photos were submitted in lieu of the set to further aid in the investigation.Photo 1 shows the front of a cpd/as5 whole blood bag.The picture confirmed that there was no clear rbc separation in the bag.Closer inspection confirmed that rbcs had separated.However, the plasma looked slightly pink tinged in the segmented tubing (to the left of the bag).Photo 2 shows the back of the whole blood bag, and another unit of spun plasma with normal color for comparison.The tubing in the whole blood bag confirmed that rbcs had separated from the plasma and the color of plasma appeared to be normal and with no hint of hemolysis.The customer confirmed that the table top centrifuge (kubota) that the customer used to separate blood components utilized rotor rs8120 with a radius of 22.4cm.Based on reported speed of 3324 rpm, the g force was determined to be 1235, well within the specifications for component separation per "overview of blood components and their preparation" by basu andkulkarni.As a result, over centrifugation did not contribute to the hemolysis of rbcs.Citation: basu, d., & kulkarni, r.(2014).Overview of blood components and their preparation.Indian journal of anaesthesia, 58(5), 529.Doi:10.4103/0019-5049.144647investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in initial reporter name and address, initial reporter health professional, and investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provided updated information in g.1 and g.2.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide in investigation: the testing records of the reported lot were reviewed and it was confirmedthat all testing results passed and met the testing criteria.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Root cause: a definitive root cause could not be determined.Possible causes for the hemolysis include but are not limited to: inappropriate handling during processing of blood; inappropriate storage conditions resulting in hemolysis of rbcs prior to component separation; inappropriate temperature setting during centrifugation; blood donor's physiology.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: the reported lot number was reviewed for any similar complaints reported by other customers.The results revealed that complaints associated with this lot number had not been reported by any other customers as of february 5, 2020.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The testing records of the reported lot were reviewed and it was confirmed that all testing results passed and met the testing criteria.All physiochemical test results of the cpd and as-5 solutions were within specification.Investigation is in process.A follow-up report will be provided.

• Brand Name: TERUFLEX BLOOD BAG SYSTEM
• Type of Device: TRIPLE TB CPD/AS-5 350ML ENG
• Manufacturer (Section D): TERUMO BCT, LTD; larne CO ; UK
• MDR Report Key: 8474015
• MDR Text Key: 146064898
• Report Number: 1722028-2019-00076
• Device Sequence Number: 1
• Product Code: KSR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2021
• Device Catalogue Number: 3BO356E8
• Device Lot Number: 181123A251
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other