MAUDE Adverse Event Report: IRIS INTERNATIONAL STATSPIN VT CENTRIFUGE; STATSPIN CENTRIFUGE

Catalog Number X00-003917-001

Device Problems Break (1069); Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/05/2015

Event Type  malfunction  

Event Description

A customer in the united states reported an rt12 rotor breakage in their statspin vt centrifuge during centrifugation.The customer stated that all broken rotor parts were contained within the centrifuge.The customer stated that (veterinary) patient samples were lost and needed to be recollected.The customer cleaned up the centrifuge using personal protective equipment (gloves).There were no injuries associated with this event.

Manufacturer Narrative

The customer did not return the rotor for investigation.The customer reported that the rotor holder was bent and the unit will be repaired.The customer did not know the rotor age or serial number.No further investigation may be carried out.(b)(4).

• Brand Name: STATSPIN VT CENTRIFUGE
• Type of Device: STATSPIN CENTRIFUGE
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277379
• MDR Report Key: 4661976
• MDR Text Key: 5607293
• Report Number: 2023446-2015-00100
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: X00-003917-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: FA-24395
• Patient Sequence Number: 1