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

Catalog Number 420351

Device Problem Unintended Movement (3026)

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

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that it was reported that a bd sero-fuge¿ 2001 centrifuge, 1 speed, 115v lid pops up open while spinning.

Event Description

It was reported that it was reported that a bd sero-fuge¿ 2001 centrifuge, 1 speed, 115v lid pops up open while spinning.

Manufacturer Narrative

H.6.Investigation summary: customer reported that the lid becomes unlatched while in operation for sero-fuge instrument a571014.No one was harmed from the exposed spinning components of the centrifuge.The centrifuge was returned to bd and inspected by a bd engineer.The engineer powered up the instrument and noted that the lid did not come unlatched after running several cycles.The engineer verified that the rotor had completely stopped before the latch would release.A replacement instrument was sent to the site.This is an unconfirmed failure of the instrument due to the issue not being able to be replicated.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 because this is not an alleged elf (early life failure) or fai (failure at install).The instrument was returned, and the investigation is noted above.The immediate correction was to send the customer a replacement instrument.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: GENERAL PURPOSE LABORATORY EQUIPMENT
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 8992590
• MDR Text Key: 193759903
• Report Number: 1119779-2019-00113
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 420351
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 08/15/2019
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other