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

Model Number SSVT-1 CENTRIFUGE

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2018

Event Type  malfunction  

Manufacturer Narrative

Customer technical support (cts) has provided a replacement ssvt-1 centrifuge.The rotor was not returned for further investigation.Beckman coulter internal identifier is (b)(4).

Event Description

The customer reported rt12 rotor broke resulting in parts escaping from their statspin ssvt-1.The customer noted shield was in used during incident and shield warning sticker was in place.No reports of harm or injury, no customer exposure, and no medical attention was received.

• Brand Name: STATSPIN SSVT-1 CENTRIFUGE
• Type of Device: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821 8000
• Manufacturer Contact: david davis ; 250 s. kraemer blvd; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 8480948
• MDR Text Key: 141225676
• Report Number: 2050012-2019-01063
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SSVT-1 CENTRIFUGE
• Device Catalogue Number: X00-003917-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/08/2018
• Date Manufacturer Received: 12/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2007
• 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