MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD SERO-FUGE 2002 CENTRIFUGE 2 SPEED WITH 12-PLACE HEAD; BD SERO-FUGE¿ 2002 CENTRIFUGE, 2 SPEED, 115V

Catalog Number 420352

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

The sero-fuge 2002 is a centrifuge designed for use in blood banks and clinical laboratories.The operator's manual indicates that to avoid physical injury, the customer should not attempt to operate the centrifuge with the lid safety latch not functioning properly nor open the centrifuge lid while the rotor is spinning.Bd quality received the customer-returned centrifuge and confirmed that the centrifuge spun with the lid open.It was determined that the front panel control board was the component that caused the failure.Quality reviewed complaints for this reported failure mode and no trend has been identified.Quality will continue to monitor for trends.

Event Description

The customer reported that the sero-fuge 2002 centrifuge continues to spin after the lid opens.The unit was taken out of service and replaced.No injuries were reported.

• Brand Name: BD SERO-FUGE 2002 CENTRIFUGE 2 SPEED WITH 12-PLACE HEAD
• Type of Device: BD SERO-FUGE¿ 2002 CENTRIFUGE, 2 SPEED, 115V
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• Manufacturer Contact: carol nieto ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 6722910
• MDR Text Key: 80437150
• Report Number: 1119779-2017-00004
• Device Sequence Number: 1
• Product Code: LXG
• 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: company representative,other
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 420352
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other