MAUDE Adverse Event Report: IRIS INTERNATIONAL VET EXPRESS; STATSPIN CENTRIFUGE

Catalog Number X00-003777-001

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 07/14/2014

Event Type  malfunction  

Event Description

Customer reported the rotor broke apart.

Manufacturer Narrative

It was reported that the centrifuge had shattered rotor and un-contained spraying of biohazardous fluid after the lid opened during centrifugation operation.Rotor breakage occurred and was un-contained.There was no damage to the lid/latch/hinge afterwards.No one was injured.Since the rotor was not returned with the unit for inspection, the age of the rotor cannot be determined.

• Brand Name: VET EXPRESS
• Type of Device: STATSPIN CENTRIFUGE
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: sudha gupta ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277272
• MDR Report Key: 4088521
• MDR Text Key: 15908423
• Report Number: 2023446-2014-00123
• 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
• Type of Report: Initial
• Report Date: 07/14/2014

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 Catalogue Number: X00-003777-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2014
• Initial Date FDA Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1