MAUDE Adverse Event Report: IRIS INTERNATIONAL CYTOFUGE; STATSPIN CENTRIFUGE

Catalog Number X00-003066-001

Device Problems Device Emits Odor (1425); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 09/23/2014

Event Type  malfunction  

Event Description

Customer reported a burning smell with low rpm.

Manufacturer Narrative

Burnt electrical smell and centrifuge spinning to slow at 600 rpm was reported.There was no report of exposure to operator or impact to pt results.Add'l complaint investigation reveals no evidence of charred material.There were no reports of injuries, visible flames, charred material, smoke emission, and the fire department was not called.Inadequate centrifugation reported at 600 rpms confirmed by photo tachometer.This may lead to inadequate cells on cytocentrifugation.

• Brand Name: CYTOFUGE
• 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: 4272842
• MDR Text Key: 5228946
• Report Number: 2023446-2014-00168
• Device Sequence Number: 1
• Product Code: IFB
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/23/2013

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: X00-003066-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2014
• Initial Date FDA Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2008
• 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