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

Device Problem Mechanical Problem (1384)

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

Event Date 07/11/2018

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 a bd sero-fuge¿ 2001 centrifuge, 1 speed, 115v was spinning with the lid open.

Manufacturer Narrative

Due to an it issue beginning on 7/3/2018.Previously filed emdr's did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.

Event Description

It was reported that a bd sero-fuge 2001 centrifuge, 1 speed, 115v was spinning with the lid open.

Manufacturer Narrative

Investigation summary: the centrifuge was returned to bd for investigation.The observations from manufacturing engineering were: observations: 1.Visual observation of a lot of use and spills.2.Evidence of customer tempering/modifications; evidence of the solenoid or latch mechanism had been replaced.3.Motor control device (triac) was shorted from mt1 to mt2.Further investigation showed evidence of a dried liquid between these two pins on the back side of the pcb which supplied power to the motor causing it to spin whenever power was applied.The low impedance short most likely caused excessive heat to build in this area which led to the burning smell.As a note the circuit board is in close proximity of the housing in this area so any liquid that may have gotten into this area could get trapped.4.The short circuit was on the pcb assembly and not the component.5.The unit was plugged in and observed to spin with the lid open or closed however the lid latch operated correctly.6.This instrument was manufactured in sep 2009, and is approximately 9 years old.Investigation conclusion: the complaint of a burning smell and spinning with the lid open was confirmed.Based on the condition and the age of the centrifuge it is apparent that it was heavily used.There were previous repairs made to the instrument but did not led to the problem.The cause was most likely due to a liquid that caused a short on the motor control component.Capa # 226876.Trends and corrective action: the alert and action level for safety related complaints is 2 and 3 respectively.There were 3 complaints related to safety in the month of july 2018.As a result, action level was reached.Quality has initiated capa pr 226876 to address ¿running with lid open¿ issue, please refer to capa for further details.Quality will continue to monitor and investigate complaints relative to this trend.

Event Description

It was reported that a bd sero-fuge¿ 2001 centrifuge, 1 speed, 115v was spinning with the lid open.

• 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: 7732434
• MDR Text Key: 115569712
• Report Number: 1119779-2018-00010
• 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,Followup
• Report Date: 10/04/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 07/11/2018; 07/11/2018
• Supplement Dates FDA Received: 09/10/2018; 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other