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

Catalog Number 420351

Device Problems Mechanical Problem (1384); Device Emits Odor (1425); Failure to Auto Stop (2938)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2017

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 received the customer-returned centrifuge and did not confirm that the centrifuge spun with the lid open.However, it was confirmed that an electrical burning smell was present when the device is plugged in.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 2001 centrifuge continues to spin after the lid opens and produces a burning smell while plugged in.The unit was taken out of service and replaced.No injuries were reported.

• Brand Name: BD SERO-FUGE 2001 CENTRIFUGE 1 SPEED WITH 12-PLACE HEAD
• Type of Device: BD SERO-FUGE¿ 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: 6748619
• MDR Text Key: 81381705
• Report Number: 1119779-2017-00005
• 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
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2006
• 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