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

Catalog Number X00-003917-001

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Eye Injury (1845)

Event Date 09/28/2010

Event Type  malfunction  

Event Description

Distributor reported to beckman coulter that its customer had previously reported that the rotor broke into pieces and resulted in centrifugal contents escaping the veterinary unit.

Manufacturer Narrative

Distributor reported that the rotor was broken into pieces on their customer's statspin vt unit and that pieces came out of the centrifuge and a small piece struck an operator's eye.There was no report of medical intervention as a result of this event.The customer also stated that the seal between the cover and the unit was not tight and they were unaware of the frequency with which the o-rings were changed.According to the distributor, its customer elected not to return the unit for further evaluation.

• Brand Name: STATSPIN VT
• 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: 4645530
• MDR Text Key: 18027073
• Report Number: 2023446-2015-00087
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2005
• 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