MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION BULK NON STER XCOAT DELPH PUMP; CENTRIFUGAL PUMP

Model Number 3ZZ164275X

Device Problem Leak/Splash (1354)

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

Event Date 05/31/2021

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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the dolphin head leaked.No consequences or impact to patient.The product was changed out.The surgery was completed successfully.

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 june 16, 2021.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 10, 11, 3331, 4210, 4307).Type of investigation: #1: 10 - testing of actual/suspected device.Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3:3331 - analysis of production records.Investigation findings: 4210 - leakage/seal.Investigation conclusions: 4307 - cause traced to component failure.The affected sample was visually inspected, it was confirmed the presence of fluid in the back housing of the pump.No other visual concerns were found.The sample was then attached to a circuit, and filled with water and connected to a vacuum source, vacuum was applied to the returned device, after few seconds air bubbles from the back housing was seen between the seal rotor and stator.That confirmed the thin crack between the seal rotor and stator.Evaluating the device found that the leak occurred between the stator and the seal pad/rotor.A retention sample from the same product code/lot number combination was obtained.The sample was attached to a circuit, and filled with water and pressurized to 1000mmhg for approximately 15 minutes with no leakage observed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: BULK NON STER XCOAT DELPH PUMP
• Type of Device: CENTRIFUGAL PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 12012622
• MDR Text Key: 264340400
• Report Number: 1124841-2021-00141
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K112229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 3ZZ164275X
• Device Catalogue Number: N/A
• Device Lot Number: ZA25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1