MAUDE Adverse Event Report: BECTON DICKINSON BD SERO-FUGE¿ 2002 2-SPEED CENTRIFUGE; GENERAL PURPOSE LABORATORY EQUIPMENT

Catalog Number 420352

Device Problem Protective Measures Problem (3015)

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

Event Date 08/05/2019

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.Device manufacture date was unavailable as the customer was unable to be reached at this time.

Event Description

It was reported that a bd sero-fuge¿ 2002 2-speed centrifuge was spinning with the lid open.

Manufacturer Narrative

H.6.Investigation summary: customer reported that the sero-fuge instrument 3560109 would immediately run after being plugged into a power source while the lid was still open.This complaint is an alleged early life failure (elf) or failure within 90 days of spare pcb assembly catalog number 421344.Serial number of spare was not disclosed.No one was harmed from the exposed spinning components of the centrifuge.The bd phone engineer order a free of charge instrument replacement.The phone engineer tried multiple times to find out if the replacement was replaced without issue.The customer did not respond.This is an unconfirmed failure of the spare part.The root cause is undetermined at this time.Assignable causes include: defective pcb assembly that controls latch release or a defective latch, customer did not install correctly.Dhr review could not occur due to the serial number of the spare not being present in the complaint.Material was not returned for investigation.The immediate correction was to send a free of charge instrument replacement.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.

Event Description

It was reported that a bd sero-fuge¿ 2002 2-speed centrifuge was spinning with the lid open.

• Brand Name: BD SERO-FUGE¿ 2002 2-SPEED CENTRIFUGE
• Type of Device: GENERAL PURPOSE LABORATORY EQUIPMENT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8956022
• MDR Text Key: 176255013
• Report Number: 2243072-2019-01876
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 420352
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 09/03/2019
• Supplement Dates Manufacturer Received: 08/06/2019
• 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