MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD SERO-FUGE¿ 2002 CENTRIFUGE, 2 SPEED, 115V

Catalog Number 420352

Device Problems Mechanical Problem (1384); Overheating of Device (1437); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2018

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¿ 2002 centrifuge, 2 speed, 115v sparked, overheated and now spins with the lid open.No injury or medical intervention.

Event Description

It was reported that a bd sero-fuge¿ 2002 centrifuge, 2 speed, 115v sparked, overheated and now spins with the lid open.No injury or medical intervention.

Manufacturer Narrative

Investigation summary:the customer reports the serofuge sparked, overheated, and now spins while the lid is open.No adverse medical impact was reported as a result of the issue.Service advised the customer to unplug the unit and discontinue due to safety hazard.The centrifuge is a single swap unit and the customer is shipped a new unit upon failure.The defective centrifuge was returned but not investigated as a part of this investigation.Centrifuges are investigated under capa (b)(4) for spinning with lid open issue.The spark and overheat can be attributed to liquid causing short on the motor component.Hazard analysis: per baltrm-sero-aph rev.1 ver.A, ¿burning smell, no injury occurred¿ related errors are identified as s2 and harm listed as ¿delayed test result leading to delayed treatment decision¿.Per baltrm-sero-aph rev.1 ver.A ¿spin with lid option¿ is identified as an s4 and harm listed as ¿severe injury to operator hand or exposure to biohazards¿.Trend analysis: the alert level and action level for ¿safety¿ complaints are 2 and 3 complaints per month respectively.There were 2 complaints for safety, which has triggered the alert level (2) for march monthly complaint trend report.Alert investigation attached to this pr.Investigation conclusion: root cause is unknown.Assignable cause for spark include liquid causing short on the motor component.

Manufacturer Narrative

Investigation summary: the complaint of a centrifuge spinning with the lid open is confirmed.The customer reports the centrifuge sparked, overheated, and now spins while the lid is open.No adverse medical impact was reported as a result of the issue.Service advised the customer to unplug the unit and discontinue due to safety hazard.The defective centrifuge was returned but not investigated as there is an open capa for centrifuges spinning with the lid open.No further action is required as the instrument was replaced and the problem was resolved.Bd instrument plant will continue to monitor for trends associated with this defect.Investigation conclusion: this is a confirmed failure of the instrument.The dhr was not available for review.The service history was reviewed for this instrument and no issues were identified.Spin with lid open is identified as an s4 severity ranking and harm listed as ¿severe injury to operator hand or exposure to biohazards¿.Root cause description: capa 226876 is designated to address this issue.

Event Description

It was reported that a bd sero-fuge¿ 2002 centrifuge, 2 speed, 115v sparked, overheated and now spins with the lid open.No injury or medical intervention.

• Brand Name: BD SERO-FUGE¿ 2002 CENTRIFUGE, 2 SPEED, 115V
• Type of Device: CENTRIFUGE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 7414851
• MDR Text Key: 105277357
• Report Number: 1119779-2018-00007
• 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,Followup
• Report Date: 01/09/2019

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: 420352
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 03/16/2018; 03/16/2018
• Supplement Dates FDA Received: 10/04/2018; 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other