MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ICP CENTRIFUGALPUMP XC STERILE; CENTRIFUGAL PUMP

Model Number 3CX*CP8

Device Problem Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular that a much higher rpm needed to flow.It is unknown when this event occurred, whether the product was changed out, or if there was any effect on the patient or results of the surgery.Terumo continues to attempt to gain more information regarding this event from the user facility.

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.For this reason, terumo (b)(4).

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 december 9, 2022.Upon further investigation of the reported event, the following information is new and/or changed: b5 (describe event or problem - added) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information) h6 (identification of evaluation codes 4114, 3221, 4315) type of investigation #1: 4114 - device not returned investigation findings: 3221 - no findings available investigation conclusions: 4315 - cause not established the affected sample was not returned so a direct investigation could not be performed, and a definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

There was no delay in the procedure and no patient harm.

• Brand Name: ICP CENTRIFUGALPUMP XC STERILE
• Type of Device: CENTRIFUGAL PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 15950031
• MDR Text Key: 308046533
• Report Number: 1124841-2022-00183
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 00699753450967
• UDI-Public: (01)00699753450967
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*CP8
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1