MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SINGLE STERILE XCOATED DELPHIN; CENTRIFUGAL PUMP

Model Number	164275X
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during out of box, the customer received an empty box of dolphin pump head and at the bottom of the box there was a written word "dummy".No patient involvement.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on september 15, 2021.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 3331, 4246, 4308).Type of investigation: 3331 - analysis of production records.Investigation findings: 4246 - transport/storage problem identified.Investigation conclusions: 4308 - cause traced to transport/storage.Pictures provided with the complaint confirm that an empty dummy box was sent to the customer.A dummy box is used to maintain spacings within a partial pump case box for the sterilization process.An internal non-conformity was created to fully investigate this situation.Production and quality documentation is in the process of being updated to prevent recurrence.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: SINGLE STERILE XCOATED DELPHIN
• Common Device Name: CENTRIFUGAL PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 12474376
• Report Number: 1124841-2021-00218
• Device Sequence Number: 17057676
• Product Code: KFM
• UDI-Device Identifier: 00699753450325
• UDI-Public: (01)00699753450325
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K112229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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: 06/30/2024
• Device Model Number: 164275X
• Device Catalogue Number: N/A
• Device Lot Number: ZH27
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1