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

Model Number	51400
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: 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 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 device history record was not performed for this report.Correction: clinical support spoke with the nurse at the facility, the doctor knew prior to the procedure that the set was expired and used the set knowingly.The nurse assured clinical support that there were no more expired sets.Root cause: based on the clinical findings, the use of the expired set was caused by operator error.
Event or Problem Description
During a conversation between the terumo bct account manager and the doctor at the customer site, the doctor disclosed that they performed a platelet-rich plasma (prp) injection the previous day on a patient with chronic foot pain using an expired set.It was reported that the doctor knew prior to the procedure that the set was expired and used the set knowingly.The patient status is reported as healthy.The disposable set is unavailable for return because it was discarded by the customer.

• Brand Name: HARVEST TERUMO
• Common Device Name: PC-30 PLATELET CONC PROCEDURE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9711753
• Report Number: 1722028-2020-00065
• Device Sequence Number: 3474996
• Product Code: ORG
• UDI-Device Identifier: 05020583514003
• UDI-Public: 05020583514003
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 02/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2017
• Device Model Number: 51400
• Device Catalogue Number: 51400
• Device Lot Number: 05Z9926
• 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: 01/24/2020
• Initial Report FDA Received Date: 02/14/2020
• 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
• Patient Age: 00044 YR
• Patient Weight: 88