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

Catalog Number 420351

Device Problem Unintended Movement (3026)

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

Event Date 07/26/2018

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 opened while the centrifuge was still spinning.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs 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 manufacturer: yes.Investigation summary: the complaint of the lid on a sero-fuge 2001 centrifuge opening before spinning is completed is not confirmed.The customer reported that the lid of the centrifuge opens when the centrifuge is slowing down, before the spin is complete.Unit was received, investigated, and the cause was not determined.During investigation, the unit spinning with the lid open was not reproducible.The rotor slowed to a stop after a complete spin cycle before the lid was unlatched.The lid was not able to be opened while the rotor was spinning.Unit was tested for speed, lid/latch operation, and timer setting, and passed all tests.Customer was sent a replacement unit and no further action is required.Bd instrument plant will continue to monitor for trends associated with this defect.Investigation conclusion: the complaint of a defective lid was not 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 complaint was not confirmed.Rationale: there is currently a capa (pr 226876) 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 opened while the centrifuge was still spinning.

• 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: 7779399
• MDR Text Key: 117163619
• Report Number: 1119779-2018-00011
• 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: 08/20/2018

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
• Device Catalogue Number: 420351
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 07/26/2018
• 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