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

Model Number 164267

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 04/02/2014

Event Type  malfunction  

Event Description

The svc repair tech (srt) reported that during routine testing of the device at the svc ctr, the latch was broken on the centrifugal drive motor.There was no pt involvement.

Manufacturer Narrative

Per the laboratory eval, the tech observed the drive motor latch to be broken.

• Brand Name: TERUMO CENTRIFUGAL SYSTEM
• Type of Device: 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: 3869873
• MDR Text Key: 4505128
• Report Number: 1828100-2014-00292
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 164267
• Device Catalogue Number: 164267
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2003
• 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