MAUDE Adverse Event Report: IRIS INTERNATIONAL STATSPIN SSVT-1 CENTRIFUGE

Catalog Number X00-003917-001

Device Problems Break (1069); Device Emits Odor (1425); Material Separation (1562); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2015

Event Type  malfunction  

Manufacturer Narrative

The centrifuge has not been returned to the manufacturer, it is not possible to determine the cause.No further investigation may be carried out.The customer will be supplied with a new centrifuge.The beckman coulter (bec) internal identifier for this report is (b)(4).Not returned to manufacturer.

Event Description

The distributor, idexx, reporting on behalf of an end user customer in the united states reported that during use the rt12 rotor broke apart in the statspin ssvt-1 centrifuge.The customer stated that they heard a sound like the motor got caught, and then popping or shattering sounds from the ssvt-1 centrifuge during operation.The customer also noted they smelled a burning smell when they opened the lid of the centrifuge.The customer indicated the rt12 rotor had failed.The customer did not report any smoke, flames or sparks or call the fire department, and did not report that any debris escaped from the centrifuge.It is not known whether the shield was in use.There were no reports of injury, direct exposure or medical attention required.There were no reports that patient samples were affected.

• Brand Name: STATSPIN SSVT-1 CENTRIFUGE
• Type of Device: CENTRIFUGE
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton avenue; chatsworth CA 91311
• Manufacturer (Section G): IRIS INTERNATIONAL; 9172 eton avenue; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton avenue; chatsworth, CA 91311 ; 8185277379
• MDR Report Key: 4961779
• MDR Text Key: 23399112
• Report Number: 2023446-2015-00207
• 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,health profession
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• 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: 07/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2006
• 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