MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V; EQUIPMENT, LABORATORY, GENERAL PURPOSE

Catalog Number 420351

Device Problem Defective Device (2588)

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

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd ds headquarters in (b)(4) has been listed as oem - (b)(4) is an oem manufacturing site.A device evaluation is anticipated but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: based on the provided serial number, this device was the 105th device of this catalog number manufactured in august of the year 2000.

Event Description

It was reported that bd sero-fuge¿ 2001 centrifuge, 1 speed, 115v was spinning when plugged in without a prompt.

Event Description

It was reported that bd sero-fuge¿ 2001 centrifuge, 1 speed, 115v was spinning when plugged in without a prompt.

Manufacturer Narrative

H.6.Investigation summary: customer reported that the sero-fuge instrument 3560105 would immediately run after being plugged into a power source while the lid was still open.No one was harmed from the exposed spinning components of the centrifuge.The bd phone engineer suggested that the customer order a new pcb assembly to install.The phone engineer tried multiple times to find out if the customer was able to order a replacement and resolve the issue.The customer did not respond.This is an unconfirmed failure of the instrument.The root cause is undetermined at this time.Assignable causes include: defective pcb assembly that controls latch release or a defective latch.Dhr review not required due to the age of the instrument.Material was not returned for investigation.The immediate correction was to suggest replacement of the pcb by the customer.Corrective action is not required as the failure mode is within allowable limits.Bd quality will continue to closely monitor trends associated with the failure of safety.H3 other text : see section h.10.

• Brand Name: BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V
• Type of Device: EQUIPMENT, LABORATORY, GENERAL PURPOSE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 9158641
• MDR Text Key: 196199967
• Report Number: 1119779-2019-00114
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 420351
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other