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

Catalog Number 420351

Device Problem Device Emits Odor (1425)

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

Event Date 09/24/2019

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 5th device of this catalog number manufactured in september of the year 2003.

Event Description

It was reported that bd sero-fuge¿ 2001 centrifuge, 1 speed, 115v was emitting a burning smell, and was spinning with the lid open.The unit has to be unplugged in order to turn it off.

Manufacturer Narrative

H.6.Investigation:customer reported a burning smell emanating from serofuge centrifuge 3930005.No fire was detected in regards to the instrument and no one was harmed.The instrument was replaced with a replacement instrument.The centrifuge was returned to bd and investigated.With power applied, the unit would start spinning without a command being given.The instrument immediately started emitting a burning smell.Confirmation of a latch failure could not occur due to the latch being dismantled by the customer.The burning smell is a confirmed failure of the instrument.The serofuge¿instrument has been designed and manufactured in such a way as to reduce, as far as possible, the risks of fire or explosion during normal use and in single fault condition.It meets the requirements of the following standards: iec 61010-1:2001 (ed.2), ul 61010-1 (ed.2), safety requirements for electrical equipment for measurement, control, and laboratory use - part 1 - general requirements all ul testing has been performed on this instrument platform and was found to be compliant with aforementioned international regulation(s).The requirements contained in the standard(s) have been satisfied: testing in single fault conditions which could cause the spread of fire outside the instrument, elimination or reduction of the sources of ignition within the instrument, and containment of a fire within the instrument, should it occur.The root cause is undetermined at this time.Assignable causes include: shorted components on circuit board, worn brushes on motor, or liquid spills into the instrument.Dhr review not required because this is not an alleged elf (early life failure) or fai (failure at install).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 h.10.

Event Description

It was reported that bd sero-fuge¿ 2001 centrifuge, 1 speed, 115v was emitting a burning smell, and was spinning with the lid open.The unit has to be unplugged in order to turn it off.

• Brand Name: BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V
• Type of Device: GENERAL PURPOSE LABORATORY CENTRIFUGE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 9177128
• MDR Text Key: 196217986
• Report Number: 1119779-2019-00115
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

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: 420351
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 09/24/2019
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other