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

Catalog Number 420352

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: n/a.Device manufacture date: unknown.Investigation: investigation summary: complaint: problem : reported on (b)(6) 2018 to biomed.Was found that centrifuge was able to start run with lid open.Safety switch to detect lid is closed is not functioning.Potential safety hazard.Troubleshooting instrument put out of service.Outcome/resolution no hazardous/injury event reported.Complaint entered.Quantity received and quantity affected 1/1.The complaint is confirmed.The centrifuge was returned to bd for investigation.The observations from manufacturing engineering were: verification testing: centrifuge was received in good condition with the lid latched in the closed position.Serofuge powered up successfully and operated in a normal way.Lid was unlatched by pressing the lid open button.Closed centrifuge and verified it latched.Set time and pressed start button to initiate spin cycle and verified serofuge spun at proper speed.Investigation conclusion: confirmed: verified complaint that serofuge can spin with lid open: stopped serofuge and opened lid, set time and started centrifuge with lid open.Serofuge spun as if the lid was closed.Root cause description: the lid switch appeared closed regardless of the state of the switch actuator lever.Since the switch was always closed the lid appeared to be closed to the control circuitry and therefore the centrifuge would start a spin cycle.This type of failure can occur from mechanical fatigue over time with regard to the instrument¿s age.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 (b)(6) 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 (baltrm-sero-aph rev.01 ver.A) has been reviewed, and no new hazards have been identified.This safety hazard is captured on page 3 of 9, line 2.0 at an s4 severity level of the risk management file.

Event Description

It was reported that a bd sero-fuge¿ 2002 centrifuge, 2 speed, 115 v continued to run while the lid was 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
• 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: 7276878
• MDR Text Key: 100524949
• Report Number: 1119779-2018-00002
• 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: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• 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: 02/08/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2018
• 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