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

Model Number SSVT-1 CENTRIFUGE

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

The beckman coulter complaint handling unit evaluated the information provided by the customer.The customer acknowledged that the centrifuge was operating without the use of the protective shield as cautioned in the instructions for use (ifu).Additionally, the customer acknowledged that the rotor was never inspected or replaced and had exceeded the expected lifespan.The centrifuge was replaced to resolve the issue.(b)(4).

Event Description

The customer reported the statspin idexx centrifuge rotor fractured during a cycle spin.The centrifuge rotor rt12 broke and some pieces escaped and hit the operator in the arm and chest.The operator was not hurt and no medical intervention or treatment was sought.

• Brand Name: STATSPIN IDEXX CENTRIFUGE
• Type of Device: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 10252700
• MDR Text Key: 199062181
• Report Number: 2050012-2020-00044
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• 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: 06/30/2020
• Date Manufacturer Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2007
• 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
• Patient Outcome(s): Other