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

Catalog Number 420351

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration 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¿ 2001 centrifuge, 1 speed, 115v continued to spine when the lid was open.No injury or medical intervention.

Manufacturer Narrative

Investigation results: investigation results: the centrifuge was returned to bd for investigation safety spins w/lid open complaint.Per complaint notes: customer reported a serofuge 2001 is able to be spun with the lid open.The customer confirmed no adverse medical impact as a result of the defect.The observations from manufacturing engineering were: instrument appears brand new.Ran through multiple test and instrument functions as intended.Centrifuge was found to be fully operational and functioning properly.Centrifuge will not initiate a spin until the lid is closed and latched.The lid remains latched until the centrifuge comes to a stop.Complaint is not confirmed.No other problem found.Device history record review is not required as a capa is open.The instrument was found to be fully functional.No root cause was determined.Trends and corrective action: the complaint trend for safety have not reached an actionable level for the march 2018.Two safety complaints were reported for the month.Cat 4 safety complaints default at a/a levels of 2 and 3 respectively within a 6 month trending period.The customer received an foc replacement as a resolution.Quality has initiated capa pr 226876 for further investigation intended to drive a corrective action for this trend.Quality will continue to monitor trends relative to the safety cat 4 code for this instrument.These complaints are captured in the risk management file, baltrm-centrifuge-rmp ver a rev 1.No new hazards have been identified and no hazards have changed.

• Brand Name: BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V
• Type of Device: CENTRIFUGE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 7446864
• MDR Text Key: 106162775
• Report Number: 1119779-2018-00008
• 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: 05/16/2018

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
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other