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 08/01/2017

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 reviewed the complaint and was unable to confirm the centrifuge spinning with the lid open.A fse was dispatched to the site and determined the rotor was worn.The centrifuge was not returned to quality for further investigation.Quality reviewed complaints for this reported failure mode and no trend has been identified.Quality will continue to monitor for trends.Device evaluated.

Event Description

The customer reported that the sero-fuge 2002 centrifuge continued to spin after the lid opens.The unit was taken out of service and repaired.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: 6823872
• MDR Text Key: 83865068
• Report Number: 1119779-2017-00007
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• 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: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2016
• 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