MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V; SEE H.10

Catalog Number 420351

Device Problem Unintended Movement (3026)

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

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.Common device name: equipment, laboratory, general purpose, labeled and promoted for a specific medical use.Initial reporter addr 1: (b)(6).Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd sero-fuge¿ 2001 centrifuge, 1 speed, 115v the unit would spin with the lid open.No patient impact.The following information was provided by the initial reporter: issue with lid or latch (b)(4).Unit spins with the led open.

Manufacturer Narrative

H.6 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, 3390059 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 3390059, 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.Complaint history for "safety" was reviewed for the month of august 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 s4, instrument malfunction resulting in customer annoyance via document baltrm-sero-aph, revision 02, row id 2.0.

Event Description

It was reported that while using bd sero-fuge¿ 2001 centrifuge, 1 speed, 115v the unit would spin with the lid open.No patient impact.The following information was provided by the initial reporter: issue with lid or latch (b)(6).Unit spins with the led open.

• Brand Name: BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V
• Type of Device: SEE H.10
• 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: 15207619
• MDR Text Key: 305272010
• Report Number: 1119779-2022-01093
• 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: 11/28/2022

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: 07/29/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/10/2022
• 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