MAUDE Adverse Event Report: BECTON DICKINSON BD SEDI-40¿; ESR INSTRUMENT

Catalog Number 361546

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).(b)(6).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 bd sedi-40¿ produced an error message and would not function.No serious injury or medical intervention was reported.

Event Description

It was reported that bd sedi-40¿ produced an error message and would not function.No serious injury or medical intervention was reported.

Manufacturer Narrative

H.6.Investigation: investigation summary: bd had performed a technical evaluation of the customer's sedi-40 instrument.It was determined that the sprocket that is mounted to the tube holder had loosened itself and was not driving the tube holder anymore.Due to the fact that it is not mixing it will generate in most cases llo since partial sedimentation was already started.Subsequently the instrument was repaired.Upon completion of the instrument evaluation, the service technician had verified that the instrument was operating within normal parameters, as documented in the instrument service report.Investigation conclusion: based on evaluation of the customer's instrument, the customer's observation of llo error message was acknowledged.Root cause description: the root cause was attributed to a hardware component that drives the tube holder and mixing process.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SEDI-40¿
• Type of Device: ESR INSTRUMENT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7915729
• MDR Text Key: 122163630
• Report Number: 2243072-2018-01474
• Device Sequence Number: 1
• Product Code: GHC
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

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: 361546
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 09/27/2018
• Supplement Dates Manufacturer Received: 08/24/2018
• Supplement Dates FDA Received: 04/04/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other