MAUDE Adverse Event Report: TERUMO BCT HARVEST TERUMO; APC-30 PROCEDURE PACK

Model Number	51404
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the customer provided a delivery slip which indicated lot 10b9942 (with an expiry date of 01 sep 2020) was used by the customer on (b)(6) 2021.Harvest product kits contain multiple components that have various expiry dates.The outer kit label contains the expiry date associated with the component that has the shortest expiry timeframe.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 follow-up report will be provided.
Event or Problem Description
Upon review of the information provided by the distributor, it was discovered that an expired havest procedure pack disposable was used on a patient.The apc-30 procedure pack disposable was labeled with an expiration date of 09/01/2020.The procedure was performed on (b)(6) 2021.Patient information and outcome are unknown at this time.The disposable 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 b.5 and h.6.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
Patient infomation and outcome are unavailable from the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, e.1, h.6 and h.10.Investigation: the customer declined to respond to the retraining offered by terumo bct clinical support.Root cause: based on the clinical findings, the use of the expired set was caused by operator error.
Event or Problem Description
After multiple follow-up attempts, patient information, further procedural details, the disposition of the collected product and status of the recipient were not provided.

• Brand Name: HARVEST TERUMO
• Common Device Name: APC-30 PROCEDURE PACK
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11333513
• Report Number: 1722028-2021-00069
• Device Sequence Number: 11708925
• Product Code: ORG
• UDI-Device Identifier: 05020583514041
• UDI-Public: 05020583514041
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK130068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: 51404
• Device Catalogue Number: 51404
• Device Lot Number: 10B9942
• 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: 01/26/2021
• Supplement Date Received by Manufacturer: 02/17/2021; 04/13/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/10/2021; 04/23/2021
• 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