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

Catalog Number 420351

Device Problems Device Remains Activated (1525); Device Operates Differently Than Expected (2913)

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

Event Date 01/07/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: n/a.Investigation: investigation summary: problem: customer reports that the centrifuge is spinning with the lid open and had a burning smell.Troubleshooting: customer confirmed centrifuge was still unplugged, advised customer cease use of centrifuge.Advised that while it is out of warranty, a replacement centrifuge would be sent.Outcome/resolution: documented complaint.Quantity received and quantity affected: one (1) received, one (1) affected.Patient impact: customer reported no adverse medical impact as a result of the failure.The customer received an foc replacement and its function.The complaint is confirmed.Investigation results: the centrifuge was returned to bd for investigation.The observations from manufacturing engineering were: serofuge 2001 sn: (b)(4).Mfg date: jan/2001.Complaint: serofuge spins with lid open.Observations: received with lid closed and latched.Could not open the lid when plugged into ac because the motor started spinning immediately.Removed latch hook to open lid and gain access to rotor.Motor spins immediately upon ac being applied regardless of lid position.Pcb has charred marks and there is evidence of some liquid around the charred area.High resistance short (12 ohms) between chassis ground and motor neutral.Triac shorted (76 ohms).Investigation conclusion: complaint is confirmed.Root cause description: motor triac is shorted causing motor to be energized when ac is applied.Evidence of a liquid spill was present and may have contributed to the malfunction.Trends and corrective action: the complaint trend for safety has not reached an actionable level at >= 3 based on a 6 month trending period.Safety issues default at an the alert level is 2 and the action level is 3, by default.There were two ¿safety¿ complaints received in december 2017.The customer received an foc replacement.Quality has initiated capa (b)(4) for further investigation intended to drive a corrective action for this trend.Quality will continue to monitor and investigate complaints relative to this trend.Risk management: the risk management file ((b)(4)) has been reviewed, and no new hazards have been identified.This safety hazard is captured on page 6, line 12.6 at s2 severity level of the risk management file.

Event Description

It was reported that a bd sero-fuge¿ 2001 centrifuge, 1 speed, 115v continued to run when the door was open.No injury or medical intervention.

• 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
• 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: 7232875
• MDR Text Key: 98878678
• Report Number: 1119779-2018-00001
• 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
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2001
• 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