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

Model Number 164275

Device Problem Decoupling (1145)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

A sample was not returned for evaluation and a lot number was not provided; therefore, a complete investigation was not able to be performed and a root cause could not be determined.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was a loss of extracorporeal perfusion and forward blood flow when using terumo sarns centrifugal pump and adapter with the sorin pump driver.It is unknown whether the product was changed out, or if there was any affect on the patient or results of the surgery.

• Brand Name: CENTRIFUGAL PUMP HEADS
• Type of Device: CENTRIFUGAL PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 5884017
• MDR Text Key: 52390001
• Report Number: 1124841-2016-00306
• 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
• Type of Report: Initial
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• 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: UNKNOWN
• Other Device ID Number: (01)30699753002334
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2016
• 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