MAUDE Adverse Event Report: TERUMO BCT HARVEST TERUMO; BONE MARROW ASPIRATE CONCENTRATE PROCEDURE PACK

Model Number	51422
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the use of an expired harvest bmac set.Patient weight is not available at this time.The device was used for treatment but not diagnosis.The set is not available for return for evaluation.
Additional Manufacturer Narrative
Fmf investigation is in process.A follow up report will be provided.
Additional Manufacturer Narrative
Additional product code: fmf investigation: a review of the certificate of compliance shows that this lot met all acceptance criteria for release.As the reported adverse event did not relate to activities associated with the manufacture of this lot, further review of the dhr was not performed for this complaint record.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.Correction: this customer was aware of the mistake and reported the issue.Hence, no retraining was required.Investigation is in process.A follow up report will be provided.
Event or Problem Description
The customer reported the use of an expired harvest bmac set.The device was used for treatment but not diagnosis.The set is not available for return for evaluation.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, h.6 and h.10.Additional product code: fmf investigation: a review of the certificate of compliance shows that this lot met all acceptance criteria for release.As the reported adverse event did not relate to activities associated with the manufacture of this lot, further review of the dhr was not performed for this complaint record.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.Correction: this customer was aware of the mistake and reported the issue.Hence, no retraining was required.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be an operator error.
Event or Problem Description
The customer reported the use of an expired harvest bmac set.The device was used for treatment but not diagnosis.Customer did not provide patient outcome.The set is not available for return for evaluation.

• Brand Name: HARVEST TERUMO
• Common Device Name: BONE MARROW ASPIRATE CONCENTRATE PROCEDURE PACK
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 15580293
• Report Number: 1722028-2022-00331
• Device Sequence Number: 6344924
• Product Code: JQC
• UDI-Device Identifier: 05020583514225
• UDI-Public: 05020583514225
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K103340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2022

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: 11/01/2021
• Device Model Number: 51422
• Device Catalogue Number: 51422
• Device Lot Number: 11D9932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 11/03/2022; 11/28/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/04/2022; 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female