MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CENTRIFUGAL SYSTEM; SARNS CENTRIFUGAL SYSTEM

Model Number 164267

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2015

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the white latch on the centrifugal drive motor was broken off.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The white clip/latch is to position and secure the centrifugal pump head disposable to the drive motor.

Manufacturer Narrative

The reported complaint was confirmed.The field service representative (fsr) confirmed that the customer discarded the latch before placing service call, but customer sent a picture of the broken latch before discarding the latch.Per fsr the customer is using a spare at this point.Fsr will be performing preventive maintenance (pm) in august, 2015 and at that time, he will ask the customer if they want the repair.No additional action will be taken at this time.

• Brand Name: TERUMO CENTRIFUGAL SYSTEM
• Type of Device: SARNS CENTRIFUGAL SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4865053
• MDR Text Key: 17307522
• Report Number: 1828100-2015-00515
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2015

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: 164267
• Device Catalogue Number: 164267
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2015
• Initial Date FDA Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1