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

Catalog Number 420351

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Based on the provided serial number, this device was the 18th device with this catalog number manufactured in dec.2005.

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: a complaint of a sero-fuge 2001 centrifuge (s/n 4240018, manufactured in april 2006) spinning with the lid open is confirmed.The customer reported that the unit was spinning spontaneously when plugged in and spinning with the lid open.The unit was received and investigated and found that the printed circuit board assembly had a shorted motor triac, causing the centrifuge to spin when plugged into the ac outlet regardless of the lid condition (open or closed).It was observed that this centrifuge was heavily used and had signs of liquid spills which could have contributed to the motor triac failure.The customer was shipped a replacement unit.No further action is required.Bd instrument plant will continue to monitor for trends associated with this defect.Investigation conclusion: the complaint of a sero-fuge 2001 centrifuge spinning with the lid open is confirmed.The service history was reviewed for this instrument and no issues were identified.Hazard analysis: this issue is listed as an s4, ¿severe injury to operators hand, exposure to biohazards¿.Root cause description: the cause was a shorted motor triac.Rationale: there is currently a capa (b)(4) looking at the reliability of the latch mechanism on sero-fuge series centrifuges.

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: EQUIPMENT, LABORATORY, GENERAL PURPOSE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 7954282
• MDR Text Key: 123371823
• Report Number: 1119779-2018-00013
• 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: 01/07/2019

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: 09/24/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 09/24/2018
• Supplement Dates FDA Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other