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

Catalog Number 53BO356E81

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported hemolysis (red tinged plasma) in a red blood cell concentrate component.Unit #: (b)(4).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.The collection set is not available for return because it was discarded by the customer.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.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, e.1, e.3, h.6 and h.10.Corrected information is provided in a.1 and h.6.Investigation: between november 6, 2019 thru november 8, 2019; a terumo clinical education specialist visited the customer site and reported the following: -the customer has performed 35,000 total collections in the month of october 2019.Of which, 15,000 were performed on the tab bag configuration.In the 261 hemolysis cases the customer reported, it was identified that 90% of those cases were from the tab 350 ml bags.This shows that 1.7% of the 15,000 collections in the tab 350 ml bags resulted in hemolysis.It is deduced that had this been a blood bag batch defect, the number of hemolysis cases would be higher.-hemolysis was observed during storage from day one (1) to day twenty-two (22) with most being observed with the first ten (10) days of storage; -hemolysis check is performed visually, there are no quantitative methods performed; -some rbc units were transfused to patients; no reactions have been reported; -90% of the collections are from mobile camp; and -visual checks of stored rbc are performed daily.A select few of the alleged hemolyzed product was tested for free plasma free hb tests using a beckman coulter spectrophotometer.Results identified 1 out of 5 visible hemolyzed rbc after 15 days of storage was at 1.18 plasma hb-g/dl (1% hemolysis).Before a terumo clinical education specialist visited the customer's, site there was a reported 261 occurrences of hemolysis (12 occurrences in september 2019 and 249 occurrences in october 2019).After the site visit on november 8, 2019; the customer noticed decrease in incidents of hemolysis in blood product when compared to october 2019.The customer reported an additional 64 occurrences of hemolysis between november 9, 2019 thru december 19, 2019.The overall number of occurrences of hemolysis over the total number of collections the customer performed gave the customer a failure rate of 0.878%.On december 20, 2019; after providing customer recommendations to reduce the potential of hemolysis, the customer modified the front plate extractor by cutting the sponge.Between december 20, 2019 and february 2, 2020; the number of additional occurrences of hemolysis reported by the customer has been 11 occurrences.The customer current rate of failure of hemolysis has decreased to 0.0765%.Terumo bct continues to work with the customer to further identify contributing factors of alleged hemolysis.The customer submitted photos for evaluation.Review of the photos show separation between red blood cells and plasma in the whole blood collection bag.However, the plasma is red tinged, a sign of possible hemolysis.Retained samples were tested for the reported lot and all testing results passed.Review of dhr of the affected lot revealed no events that would influence the hemolysis as reported.All physiochemical test results of the cpd and as-5 solutions were within specification.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 3, 2020.Translation of the labels the customer placed on the whole blood bag unit states: "do not use if there is hemolysis, color, abnormal signs." correction: based on the on-site visit to customer's facility, the following was recommended: -reduce centrifugation to 3200 rpm and time to 12 minutes -avoid applying pressure on bottom tubing during separation and extraction -gently add as-5 solution and take caution when mixing after separation -recheck storage temperature at various storage points to ensure temperature outside the bag stays within specification -a quantitative method should be considered to ensure unit is not hemolyzed -ensure gentle mixing -adapt safety features to prevent potential bacterial contamination and hemolysis -proper arrangement may be adopted to ensure proper temperature across the bags and prevent damage to bag on december 20, 2019 the customer modified the front plate extractor by cutting the sponge.As of february 2, 2020; the number of additional occurrences of alleged hemolysis reported by the customer has been 11 total occurrences.Terumo bct is continuing to work with the customer to monitor rate of hemolysis at their site and identify additional contributing factors for the alleged hemolysis.Root cause: a definitive root cause could not be determined.Possible causes identified after customer site visit include but are not limited to: -centrifugation: first spin was 3320 rpm at 13 minutes -processing: occlusion due to squeezed bottom tubes at the end of separation leading to "time out" (greater than 105 seconds); size of the bag smaller than the front plate of extractor causing high chances of pressure on bottom tubes, mixing of rbc with as-5 after separation -storage temperature low -hemolysis assessment techniques performed by visual assessment -blood collection-in house: pressing of bag when mixing, no safety feature system on the bag -pre-centrifugation: clutter of bags in the bin.

Event Description

Per the customer some rbc units were transfused to patients; no reactions have been reported.It is unknown which units were transfused and which discarded.After multiple follow ups the customer declined to provide patient information.

• Brand Name: TERUFLEX BLOOD BAG SYSTEM
• Type of Device: TRIPLE TB CPD/AS-5 350ML ENG
• Manufacturer (Section D): TERUMO BCT LTD; larne ; UK
• MDR Report Key: 9404200
• MDR Text Key: 191438299
• Report Number: 3001980567-2019-00187
• Device Sequence Number: 1
• Product Code: CAK
• 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
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2022
• Device Catalogue Number: 53BO356E81
• Device Lot Number: 190520C151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other