MAUDE Adverse Event Report: IRIS INTERNATIONAL STATSPIN SSVT-1 CENTRIFUGE; CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Catalog Number X00-003917-001

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 07/05/2017

Event Type  malfunction  

Manufacturer Narrative

Customer technical specialist (cts) advised customer to return the unit.Customer returned ssvt - 1 centrifuge for investigation.Only the centrifuge was received, rotor was not returned.Upon visual inspection of the centrifuge, noted the hinge on the lid was broken.(b)(4).

Event Description

The customer reported the rt12 rotor broke during centrifugation of the statspin ssvt-1 centrifuge.The customer stated that the safety shield was in use at the time of the event.The customer stated that pieces of the rotor had escaped from the ssvt- 1 centrifuge.There are no reports of harm or injury, no customer exposure, and no medical attention was received due to this event.

• Brand Name: STATSPIN SSVT-1 CENTRIFUGE
• Type of Device: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
• 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: 6751302
• MDR Text Key: 81328410
• Report Number: 2023446-2017-00007
• Device Sequence Number: 1
• Product Code: JQC
• UDI-Device Identifier: 10873037000278
• UDI-Public: (01)10873037000278(11)NO-DATA
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2010
• 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