MAUDE Adverse Event Report: TERUMO BCT COBE 2991; COBE 2991 WASHING KIT

Catalog Number 90819

Device Problems Contamination /Decontamination Problem (2895); Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

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

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they had product from the 2991 cobe (wash cells) that failed the sterility testing.Per the customer, they believe the contamination is likely human error, not device-related.The customer destroyed the product, therefore, there was not a transfusion recipient or patient involved and no patient information is reasonably known at the time of the event.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 g.2, 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.A disposable history search indicated there were no other reported occurrences of microbial contamination on this lot worldwide.Per internal lab documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

• Brand Name: COBE 2991
• Type of Device: COBE 2991 WASHING KIT
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10488622
• MDR Text Key: 206188868
• Report Number: 1722028-2020-00424
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: K893962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

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: 09/01/2021
• Device Catalogue Number: 90819
• Device Lot Number: 09C15003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other