MAUDE Adverse Event Report: BECTON, DICKINSON & CO. SERO-FUGE¿ 2001 CENTRIFUGE 1 SPEED WITH 12-PLACE HEAD; SEROFUGE 2001 CENTRIFUGE, 1 SPEED, 115V

Catalog Number 420351

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2017

Event Type  malfunction  

Manufacturer Narrative

The sero-fuge 2001 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 investigation confirmed that the sero-fuge 2001 centrifuge did continue to spin after the lid was unlatched.The centrifuge lid was able to be opened in the middle of the cycle, but opening the lid did cut the power to the centrifuge.Quality reviewed complaints for this reported failure mode and no trend has been identified.Quality will continue to monitor for trends.Device returned on 21-jan-17 and evaluated by manufacturer.

Event Description

The customer reported that the sero-fuge 2001 centrifuge continues to spin after the lid opens.The unit was taken out of service and replaced.No injuries were reported.

• Brand Name: SERO-FUGE¿ 2001 CENTRIFUGE 1 SPEED WITH 12-PLACE HEAD
• Type of Device: SEROFUGE 2001 CENTRIFUGE, 1 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: 6297044
• MDR Text Key: 66775675
• Report Number: 1119779-2017-00001
• 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: health professional,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 420351
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other