MAUDE Adverse Event Report: TERUMO BCT HARVEST TERUMO; PC-30 PLATELET CONC PROCEDURE SET

Catalog Number	51400
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a terumo bct sales representative initially contacted a customer from (b)(6) as a prospective account.Per the customer, the smp2 had not been used "in a longtime".The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported that a pc-30 harvest set that had been expired for approximately 12 years was used while attempting to isolate some growth factors.The support specialist reach out to the customer and instructed them to stop using the product.During subsequent follow-up with the customer, the customer confirmed that they had disposed of the product, the patient was doing 'fine' and they are pleased with the patient's outcome.The customer declined to provide the patient information.The pc-30 harvest set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in correctedinformation in investigation: the harvest set used was not sold to the customer by terumo bct.Thecustomer is not a customer of terumo bct and did not have any binding agreements withterumo bct at the time of usage.This product was purchased before the sell of the harvestproduct line to terumo bct, therefore no records are available for review.The initial reporter facility was not provided, terumo bct is listed as a default location.Thecustomer was contacted as a sales call and it is unknown where the procedure was performed.The customer support specialist had a conversation with the customer and provided rationale tothe customer for not using expired kits.The customer confirmed verbally that the remainder ofthe expired sets were discarded.No further customer training is required.Root cause: the root cause of the usage of the expired disposable was human error by thecustomer.

• Brand Name: HARVEST TERUMO
• Common Device Name: PC-30 PLATELET CONC PROCEDURE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8464067
• Report Number: 1722028-2019-00068
• Device Sequence Number: 19240878
• Product Code: ORG
• UDI-Device Identifier: 05020583514003
• UDI-Public: 05020583514003
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: BK130068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 51400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other