MAUDE Adverse Event Report: BECKMAN COULTER STATSPIN SSVT 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 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

Beckman coulter initiated an rma (return material authorization) for replacement of the customer¿s centrifuge.The distributor, (b)(4), supplied a new replacement unit to the customer to resolve the issue.Beckman coulter internal identifier is (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, traveled a few feet and hit a cabinet.There are no reports of harm or injury; thus, no medical attention was received due to this event.

• Brand Name: STATSPIN SSVT 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.; m/s e1.se.01; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 7589309
• MDR Text Key: 111164128
• Report Number: 2050012-2018-01001
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2018

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
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2011
• 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