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

Model Number SSVT-1 CENTRIFUGE

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

Patient Problem No Patient Involvement (2645)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported the rt12 rotor broke during centrifugation of the statspin ssvt-1 centrifuge, and pieces of tube hit doctor's arm.Pieces of the tube traveled about 2-3 feet out of the centrifuge.The customer stated that the safety shield was in use at the time of the event.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): 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: 7589305
• MDR Text Key: 111299192
• Report Number: 2050012-2018-01002
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/15/2018
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/23/2007
• 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