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

Catalog Number 420352

Device Problem Self-Activation or Keying (1557)

Patient Problem No Information (3190)

Event Date 03/05/2018

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 sero-fuge¿ 2002 centrifuge, 2 speed, 115v continued to run when the lid was open.No injury or medical intervention.

Manufacturer Narrative

Investigation summary: complaint was confirmed.The centrifuge was returned to bd for investigation of the safety spins w/lid open complaint.Customer reported an out of warranty centrifuge spins while the lid is open.The customer confirmed the receipt and proper operation of the replacement.The observations from manufacturing engineering were: instrument shows signs of moderate use.Evidence of some liquid spills that leaked into the latch mechanism.Some customer tampering with the lid latch was evident.A piece of foam tape was applied to the top of the latching mechanism for an unknown reason.Lid latch mechanism was found to be sticky and got hung up but centrifuge would not spin unless the lid is closed and latched.It was noted that the latch mechanism could be defeated if the latch hook was bent slightly.In this scenario the operator would have noticed that the lid was not fully closed or latched and should not have tried to initiate a spin cycle.Investigation conclusion: based on returns investigation, the cause can be attributed to but not limited to wear due to liquid spill and tampering by the customer.As received the centrifuge operated correctly even though the latch mechanism was somewhat impaired and in need of replacement.The dhr was unable to be retrieved.The service history was reviewed for this instrument and no issues were identified.Root cause description: assignable cause include wear due to liquid spill and customer tampering with lid mechanism.Rationale: the complaint trend for safety has 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 (b)(4) 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, (b)(4).No new hazards have been identified and no hazards have changed.

Event Description

It was reported that a bd sero-fuge¿ 2002 centrifuge, 2 speed, 115v continued to run when 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: 7387318
• MDR Text Key: 104157562
• Report Number: 1119779-2018-00005
• 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: 01/09/2019

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: 420352
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/30/2018
• Supplement Dates Manufacturer Received: 03/05/2018
• Supplement Dates FDA Received: 01/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other