MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD SERO-FUGE¿ 2002 CENTRIFUGE, 2 SPEED, 115V; SEE H10

Catalog Number 420352

Device Problem Unintended Movement (3026)

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

Event Date 07/07/2022

Event Type  malfunction  

Manufacturer Narrative

In this mdr, bd ds headquarters in (b)(4) has been listed as the drucker co., inc.Is an oem manufacturing site.Common device name: equipment, laboratory, general purpose, labeled and promoted for a specific medical use 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 during use with the bd sero-fuge¿ 2002 centrifuge, 2 speed, 115v, the rotor spun with the lid unlocked.There was no report of user impact.The following information was provided by the initial reporter: customer mentioned that the rotor spins while the lid is unlocked.Advised the customer to stop using the unit and use extreme caution when troubleshooting any issues.

Manufacturer Narrative

H6 investigation summary: root cause is not determined, and this complaint is not a confirmed failure of the instrument as the instrument was not returned to investigate.Review of device history record for instrument serial number, 3560134 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.Service history review was performed for the instrument 3560134, and no additional work orders were observed for the complaint failure mode reported.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 ¿safety.¿ capa is not required as no trends were identified.Complaint history for "safety" was reviewed for the month of july 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.

Event Description

It was reported that during use with the bd sero-fuge¿ 2002 centrifuge, 2 speed, 115v, the rotor spun with the lid unlocked.There was no report of user impact.The following information was provided by the initial reporter: customer mentioned that the rotor spins while the lid is unlocked.Advised the customer to stop using the unit and use extreme caution when troubleshooting any issues.

• Brand Name: BD SERO-FUGE¿ 2002 CENTRIFUGE, 2 SPEED, 115V
• Type of Device: SEE 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: 15077027
• MDR Text Key: 301260778
• Report Number: 1119779-2022-01013
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 10/21/2022

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: 420352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 10/21/2022
• Supplement Dates FDA Received: 11/02/2022
• 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