MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD SERO-FUGE 2002 CENTRIFUGE, 2 SPEED, 115V; SEE H.10

Catalog Number 420352

Device Problem Unintended System Motion (1430)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

For oem manufacturing sites: (b)(4).Common device name: equipment, laboratory, general purpose, labeled and promoted for a specific medical use.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported while using bd sero-fuge¿ 2002 centrifuge, 2 speed, 115v the lid unlocked while spinning.There was no user impact.The following information was provided by the initial reporter: it was reported that unit had finished the cycle and it unlock while still spinning down for sn (b)(4).Additionally, the bd sales consultant provided the following additional information: steps taken with customer/troubleshooting: unit is out of warranty as it was manufactured in september 2011.Customer stated cycle was finished but rotor is still spinning down and the lid unlocked.Customer confirmed that no injury occurred as user waited for rotor to fully stop before opening the lid.Discussed with customer possibility of motor or pcb being defective.Recommended customer reseed ribbon cable for keypad that runs to pcb and clean off connections.If that does not resolve the issue, recommended customer inspect pcb and motor for any defects.Advised customer that product line has been discontinued.

Event Description

It was reported while using bd sero-fuge¿ 2002 centrifuge, 2 speed, 115v the lid unlocked while spinning.There was no user impact.The following information was provided by the initial reporter: it was reported that unit had finished the cycle and it unlock while still spinning down for sn (b)(6).Additionally, the bd sales consultant provided the following additional information: steps taken with customer/troubleshooting: unit is out of warranty as it was manufactured in september 2011.Customer stated cycle was finished but rotor is still spinning down and the lid unlocked.Customer confirmed that no injury occurred as user waited for rotor to fully stop before opening the lid.Discussed with customer possibility of motor or pcb being defective.Recommended customer reseed ribbon cable for keypad that runs to pcb and clean off connections.If that does not resolve the issue, recommended customer inspect pcb and motor for any defects.Advised customer that product line has been discontinued.

Manufacturer Narrative

Investigation summary: customer reported that serofuge instrument (catalog number 420352) serial number (b)(6) lid unlocks while rotor is still spinning.The customer indicated cycle was finished but the rotor is still spinning down and the lid unlocked.Customer confirmed no injury occurred as the user waited until the rotor fully stopped before opening the lid.The customer was informed the centrifuge is out of warranty and has been discontinued.Customer took centrifuge out of service.Review of device history record for 4890036 is not needed due to the age of the instrument.Root cause is not determined and this complaint is not confirmed as no material was returned for investigation.There are no corrective action plans or other corrections occurring.Bd quality will continue to closely monitor trends associated with the failure of ¿safety.¿.

• Brand Name: BD SERO-FUGE 2002 CENTRIFUGE, 2 SPEED, 115V
• Type of Device: SEE H.10
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11646079
• MDR Text Key: 244922923
• Report Number: 1119779-2021-00644
• 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: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 420352
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• Supplement Dates FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1