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

Catalog Number X00-003917-001

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

Patient Problem No Patient Involvement (2645)

Event Date 04/07/2014

Event Type  malfunction  

Event Description

Customer reported rotor failure leading to breakage of internal parts during operation causing spillage.

Manufacturer Narrative

Statspin centrifuge rotor breakage during operation caused feline blood products/fluids spillage; un-contained outside of centrifuge.The lid of centrifuge broke-off at the hinge.Customer reported that the centrifuge drive was still spinning until it was unplugged.No injuries reported including during clean-up.A ring of blood exists in the bowl of the centrifuge, that there was blood and debris on the bench.The feline sample was from an animal that did not have any disease infections of either animals, or humans, and did not have any disease reportable to the fda or usda.Customer did not know when rotor rt12 was last replaced.

• Brand Name: STATSPIN MP
• 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: 3902117
• MDR Text Key: 17578964
• Report Number: 2023446-2014-00050
• Device Sequence Number: 1
• Product Code: GKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K920759
• 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: 04/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2001
• 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