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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD SEDI-40; ESR INSTRUMENT
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BECTON DICKINSON BD SEDI-40; ESR INSTRUMENT Back to Search Results
Catalog Number 361546
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/19/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.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.Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) , has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
 
Event Description
It was reported that bd sedi-40 had a hardware malfunction.The following information was provided by the initial reporter: "the exhaust fan is making rattle noises.Mixer cover is broken.Please check instrument sensor reading because the laboratory find out significant differences between the results compared with another sedi 40 instruments in the laboratory.Customer made test comparison with a hospital nurse blood sample and esr was increased.Also during a batch readings some samples were not red but produced llo error although tubes were filled correctly.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.H6: investigation summary.Instrument sedi 40 (b)(6) was returned to the manufacturer for service with respect to the reported defect ¿ noisy fan, crack in tube cover, and llo flagging.The instrument was evaluated by visual examination and functional testing and the noisy fan was found to be caused by sticker material on top of the fan.This was cleaned and the fan is operating as expected.Some cracks were observed in the tube cover so it was replaced.The functional testing concluded that the instrument is working as expected.The reported results discrepancy and llo flagging was likely caused by insufficiently mixed tubes.Five minutes of mixing is not always sufficient especially when tubes have been standing for a long time a compact pallet of red cells is created.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformances during manufacturing of the product.H3 other text : see h10.
 
Event Description
It was reported that bd sedi-40 had a hardware malfunction.The following information was provided by the initial reporter: "the exhaust fan is making rattle noises.Mixer cover is broken.Please check instrument sensor reading because the laboratory find out significant differences between the results compared with another sedi 40 instruments in the laboratory.Customer made test comparison with a hospital nurse blood sample and esr was increased.Also during a batch readings some samples were not red but produced llo error although tubes were filled correctly.".
 
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Brand Name
BD SEDI-40
Type of Device
ESR INSTRUMENT
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11703218
MDR Text Key253171128
Report Number2243072-2021-01214
Device Sequence Number1
Product Code GHC
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 04/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number361546
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2021
Date Manufacturer Received04/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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