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

Catalog Number 420351

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd ds headquarters in (b)(4) has been listed in sections as oem - (b)(4).Is an oem manufacturing site.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 101st device with this catalog number manufactured in nov.2001.

Event Description

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

Event Description

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

Manufacturer Narrative

Investigation summary: the complaint of a sero-fuge 2001 centrifuge (s/n: (b)(4), manufacture date: november 2001) is spinning with the lid open is confirmed.The customer reported that the centrifuge was spinning with the lid open.The customer was advised that the unit was posing a safety hazard and should be unplugged and returned.The centrifuge was received and investigated.During investigation, the centrifuge was not spinning with the lid open, but was not initiating spin at all.The centrifuge would continuously beep when a key was pressed.The root cause was a defective pcb assembly.A replacement unit was shipped to the customer.Investigation conclusion: the complaint of spinning with lid open was 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 defective pcb assembly.Rationale: there is currently a capa ((b)(4)) looking at the reliability of the latch mechanism on sero-fuge series centrifruges spinning with the lid open.No further action is required at this time.Bd instrument plant will continue to monitor trends associated with this defect.

• 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: 8061162
• MDR Text Key: 127073881
• Report Number: 1119779-2018-00014
• 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: 01/15/2019

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: 10/29/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other