MAUDE Adverse Event Report: BECTON, DICKINSON & CO. SERO-FUGE 2002 CENTRIFUGE; CENTRIFUGES, EQUIPMENT, AND SUPPLIES

Catalog Number 420352

Device Problem Self-Activation or Keying (1557)

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

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd sero-fuge¿ 2002 centrifuge, 2 speed, 115v was spinning with the lid open.No injuries were reported.The following information was provided by the initial reporter: " customer reports that, out of warranty sn (b)(4), unit will spin with lid opened and without pressing start.".

Manufacturer Narrative

H.6.Investigation summary : customer reported that the serofuge instrument 3880069 would spin while the lid was still open.The customer indicated that if the lid was opened during operation, the instrument would not stop spinning; however, no one was harmed.The customer ordered a pcb assembly to repair the unit.After repair, the unit functioned as expected.This is the second unit in the customer's possession to experience this issue.This is a confirmed failure of the system due to a history of this failure occurring.Assignable causes include: defective pcb assembly that controls latch release, defect latch, or defective board level component.Investigation of material could not occur as material was not returned.The immediate correction was for the customer to order a replacement pcb.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¿ 2002 centrifuge, 2 speed, 115v was spinning with the lid open.No injuries were reported.The following information was provided by the initial reporter: " customer reports that, out of warranty sn 3880069, unit will spin with lid opened and without pressing start.".

• Brand Name: SERO-FUGE 2002 CENTRIFUGE
• Type of Device: CENTRIFUGES, EQUIPMENT, AND SUPPLIES
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 10011159
• MDR Text Key: 204946745
• Report Number: 1119779-2020-00076
• 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: 06/15/2020

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: 04/08/2020
• Initial Date FDA Received: 04/29/2020
• Supplement Dates Manufacturer Received: 04/08/2020
• Supplement Dates FDA Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other