MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V; SEE SECTION H10

Catalog Number 420351

Device Problem Unintended Movement (3026)

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

Event Date 05/18/2022

Event Type  malfunction  

Manufacturer Narrative

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 that the bd sero-fuge¿ 2001 centrifuge, 1 speed, 115v rotor began spinning when plugged in despite the lid remaining open.There was no report of adverse user or patient impact.The following information was provided by the initial reporter: "keypad/timer issue; sn (b)(4).Customer reports centrifuge spins with lid open.Biomed technician reports the rotor starts spinning once the centrifuges is plugged into power outlet and while the lid is open.Customer is no longer using the instrument.Customer confirms no safety incidents to report.".

Event Description

It was reported that the bd sero-fuge¿ 2001 centrifuge, 1 speed, 115v rotor began spinning when plugged in despite the lid remaining open.There was no report of adverse user or patient impact.The following information was provided by the initial reporter: "keypad/timer issue; sn (b)(6).Customer reports centrifuge spins with lid open.- biomed technician reports the rotor starts spinning once the centrifuges is plugged into power outlet and while the lid is open.- customer is no longer using the instrument.- customer confirms no safety incidents to report.".

Manufacturer Narrative

H.6.Investigation summary: customer reported keypad issue on serofuge instrument (catalog number 420351) serial number (b)(6).The customer indicated the serofuge centrifuge rotor starts spinning once it is plugged into power outlet and the lid is still open.Customer reported no adverse user or patient impact.Customer is no longer using the instrument.Advised customer to have instrument evaluated by a qualified technician.Informed customer the product is discontinued, and no spare parts are available.Root cause is not determined, and this complaint is not a confirmed failure of the instrument based on the customer investigation.Review of device history record for instrument serial number, (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.Review of risk management files confirms there are no new or modified risks associated with this failure mode.There are no corrective action plans or other corrections occurring.Bd quality will continue to closely monitor trends associated with the failure of ¿display / indicators / keypad.¿ capa is not required as no trends were identified.Complaint history for "display / indicators / keypad" was reviewed for the month of may 2022.The upper control limit was not breached, and trends were not identified associated with this defect.Review of risk management documentation indicates that the potential risk of the reported failure mode was assessed as severity s3, centrifuge not functioning correctly, and operator is aware resulting in customer annoyance via document baltrm-oemcent-aph, revision 01, row id 13.8.

• Brand Name: BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V
• Type of Device: SEE SECTION H10
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14700327
• MDR Text Key: 302785921
• Report Number: 1119779-2022-00871
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

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: 420351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/15/2022
• Supplement Dates Manufacturer Received: 08/29/2022
• Supplement Dates FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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