MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD DYNAC III CENTRIFUGE (120V)

Model Number BD DYNAC¿ III CENTRIFUGE (120V)

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2017

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 dynac¿ iii centrifuge (120v) continues to run while the door is open.No injury or medical intervention.

Manufacturer Narrative

The centrifuge's dysfunction was confirmed.Per service notes: no adverse affects occurred as a result of this complaint.Because no root cause has been determined, no corrective action requiring a design and/or manufacturing process change.Safety with lid open complaints are within trending limits per the 12 month reporting period thus no new trends have been identified.Action levels have not been reached >=3.The risk management file, (b)(4) has been reviewed and no new risks have been determined as these complaints have been captured in the file.Quality will continue to monitor increasing trends that may require action as per (b)(4).No new hazards have been identified and no hazards have changed.Conclusion: an absolute root cause for this incident cannot be determined.

• Brand Name: BD DYNAC III CENTRIFUGE (120V)
• 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: 7075100
• MDR Text Key: 93889326
• Report Number: 1119779-2017-00009
• 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: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BD DYNAC¿ III CENTRIFUGE (120V)
• Device Catalogue Number: 420104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other