MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CENTRIFUGAL PUMP HEADS

Model Number 164275

Device Problems Crack (1135); Particulates (1451)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2023

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, 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.Component code: 925 - pump.Health effect - impact code: 2645 - no patient involvement.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 1135 - crack.Investigation findings: 3233 - results pending completion of investigation.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, they noticed a cracked centrifugal disposable pump.No patient involvement.Product was changed out.Procedure completed successfully.

Event Description

The event was initially reported for a crack in the pump.However, when the actual sample was returned and inspected, it was found that the event was for a foreign matter inside the pump instead of a crack.

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 february 14, 2023.Upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H6 (identification of evaluation codes 1451, 10, 11, 3331, 202, 25).Medical device problem code: 1451 - particulates.Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 202 - inappropriate material.Investigation conclusions: 25 - cause traced to manufacturing.The returned sample was inspected upon receipt and confirmed to have a piece of clear plastic inside of the pump that measured out of specification.A retention sample from the same lot number was inspected and confirmed to not have any foreign materials within it.All pumps are 100% visually inspected in process.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CENTRIFUGAL PUMP HEADS
• 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: 16371898
• MDR Text Key: 309584671
• Report Number: 1124841-2023-00047
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 00699753002333
• UDI-Public: (01)00699753002333
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

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
• Device Operator: Health Professional
• Device Model Number: 164275
• Device Catalogue Number: N/A
• Device Lot Number: 2H22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 03/16/2023
• Supplement Dates FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2022
• 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