MAUDE Adverse Event Report: IRIS INTERNATIONAL STATSPIN SSMP CENTRIFUGE

Catalog Number X00-004998-001

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2015

Event Type  malfunction  

Manufacturer Narrative

The customer did not report of any other damage to the centrifuge at the time of the event.The customer is not aware of when the rotor or o-ring were last replaced.The customer was provided with a new centrifuge by the distributor, idexx.No further investigation may be carried out.The beckman coulter (bec) internal identifier for this report is (b)(4).

Event Description

The customer states during use the rt12 rotor broke apart in their statspin ssmp centrifuge.The customer indicated that parts did escape from the centrifuge at the time of failure.No personnel were injured by the debris.The customer indicated that they were spinning one blood tube and one counterbalance tube and when the rotor broke the counterbalance tube broke, spilling water, but the blood tube was not spilled.There were no injuries upon cleaning it up.

• Brand Name: STATSPIN SSMP CENTRIFUGE
• Type of Device: STATSPIN SSMP 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: 4917052
• MDR Text Key: 22421018
• Report Number: 2023446-2015-00199
• 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: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: X00-004998-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2007
• 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