MAUDE Adverse Event Report: TERUMO BCT COBE 2991; BCP 2991

Catalog Number 90819

Device Problems Fluid/Blood Leak (1250); Contamination /Decontamination Problem (2895); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported a blood microleak at the rotating part of the set used in the cobe 2991 for the reduction of bone marrow.The leak was seen during the set removal.During centrifugation, they noted the presence of dry blood on the machine, but were unable to determine the location of the microleak during the run.There was no alarm.No significant amount of product was lost, but after analysis, it was determined that the product was not sterile.Coccis gram+ contamination was found.Unit id #: 69200017540 patient information is not available at this time.It is unknown at this time if the product was transfused.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in a.1, b.5, h.6, and h.10.Investigation: the disposable lot query was performed for lot 06d15005 and no similar contamination reported occurrences were received against this lot to date.The customer reported that the culture was positive for gram-positive cocci bacterial species.Per literature review, gram-positive cocci include staphylococcus (catalase-positive), which grows clusters and streptococcus (catalase-negative), which grows in chains.Sizar o, unakal cg.Gram positive bacteria.[updated 2020 jul 20].In: statpearls [internet].Treasure island (fl): statpearls publishing; 2020 jan-.Available from: https://www.Ncbi.Nlm.Nih.Gov/books/nbk470553/ per internal sterility documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

Event Description

There was not a transfusion recipient or patient involved at the time of this incident, therefore no patient information is reasonably known at the time of the event.

Event Description

After multiple attempts were made to retrieve additional information but the customer did not respond.Therefore, further proceudral details are not available for this event.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation : a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A foolow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Corrected investigation: the statement " the customer reported that the culture was positive for gram- positive cocci bacterial species.Per literature review, gram-positive cocci include staphylococcus (catalase-positive), which grows clusters and streptococcus (catalase-negative), which grows in chains.Sizar o, unakal cg.Gram positive bacteria.[updated 2020 jul 20].In: statpearls [internet].Treasure island (fl): statpearls publishing; 2020 jan-.Available from: https://www.Ncbi.Nlm.Nih.Gov/books/nbk470553/" provided in the first supplement is no longer relevant to this event and has been removed from the investigation.Root cause: a definitive root cause could not be determined.It is possible the micro leak was likely the cause for the microbial contamination.Possible causes for the leak include but are not limited to: - seal weight of the 2991 bcp machine binds on the metal posts, restricting the movement of the seal weight during spin cycles.This can cause the proper amount of weight to not be applied onto the rotating seal, resulting in a leak.Corrective action involves the facility cleaning the metal posts and seal weight and/or service to this assembly to allow free movement of the seal weight.Each seal weight is matched to a particular cobe 2991; seal weights are not interchangeable.Additionally, ensuring the weight travels freely the entirety of the post is ideal.Posts have been bent in the past causing movement issues.- improper loading can also lead to potential leaks.If excessive force is applied to the rotating seal it may change the internal dynamics leading to issues during centrifugation.- clamping of lines using hemostats so that flow during superout is restricted (even for a few seconds).Excess pressure (>10 psi) across the rotating seal can potentially occur and cause the leak failure of the rotating seal.- discontinuous processing of the fluid so that the centrifuge is motionless for an extended period of time can result in the ceramic faces adhering together.Upon restarting of the process, the rotating seal can potentially fail due to the stuck ceramic components.Literature supplied with the tubing kits advises that processing should be continuous and that procedure delays should not extend more than three minutes.- beginning the centrifuge spin without fluid in between the ceramic seals.The fluid in the set acts as a lubricant.If the centrifuge starts spinning without the lubricant, the ceramic seal¿s friction will cause enough heat for the two pieces to become mechanically seized together.Since the top ceramic seal is designed to remain stationary, the twisting force is transferred to one of the tubes and can cause them to separate and become a leak path.- running the centrifuge spin without fluid in between the ceramic seals.Fluid should always be visible above the routing seal to ensure the seal is well lubricated and heat transfer can properly take place.

• Brand Name: COBE 2991
• Type of Device: BCP 2991
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11147376
• MDR Text Key: 227737085
• Report Number: 1722028-2021-00009
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/11/2021

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: 06/01/2022
• Device Catalogue Number: 90819
• Device Lot Number: 06D15005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 02/18/2021; 03/04/2021; 03/24/2021
• Supplement Dates FDA Received: 02/24/2021; 03/18/2021; 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other