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

Catalog Number 420352

Device Problems Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 continued to run while the lid was open.No injury or medical intervention.

Manufacturer Narrative

The complaint is confirmed.Investigation results: the centrifuge was returned to bd for investigation.The observations from manufacturing engineering were: the (b)(4) serial number indicates a manufacture of june of 2006, making the instrument 11 years old thereby increasing the likelihood that the failed lid switch is due to normal wear and tear.The lid switch failed in a shorted condition creating an appearance of a closed position in the electronic circuitry.Therefore, the operator was able to initiate a spin cycle with the lid in the open position.Investigation conclusion: root cause: a shorted lid switch due to a loose solenoid attached to the lid mechanism.Trends and corrective action: quality will continue to monitor trends that may require action for this instrument per baltdop0172.Capa # (b)(4) has been initiated for further investigation.Per baltrm-sero-aph no new hazards have been identified.

• 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
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7151413
• MDR Text Key: 96020032
• Report Number: 1119779-2017-00011
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 420352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other