MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ SAMPLE PREP ASSISTANT III; SEE H.10.

Model Number 647205

Device Problems Fluid/Blood Leak (1250); Free or Unrestricted Flow (2945)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Common device name: automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.

Event Description

It was reported that bd facs¿ sample prep assistant iii continuous flooding of instrument has occurred after several cleaning's.The following information was provided by the initial reporter: continuous flooding of instrument, even after multiple filter cleaning's occurred.The leak appears to be a biohazard liquid.The leakage did not come in contact to personnel and no injuries were reported.

Manufacturer Narrative

H.6 investigation summary (b)(4) pn: 647205 spaiii sn: (b)(6).Awareness: 12/13/2022.Opened: 12/13/2022.Investigation summary: scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6).Problem statement: customer reported: continuous flooding of instrument manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 13dec2021 to date 13dec2022 (rolling 12 months) complaint trend: there are 2 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 13dec2021 to date 13dec2022 (rolling 12 months) investigation result / analysis: per fse¿s report: cleared the clog from the waste pump.Flushed the in-line waste filter and fittings assembly.Verified clear flow of fluid from the wash tower to the waste tank.No further issues sample preparation was not affected.There was no delay in patient treatment due to any unexpected results.Service max review: review of related work order#: wo - (b)(4).Install date: 01jul2010.Defective part number: there were no defective parts work order notes: subject / reported: continuous flooding problem description: fluid leak cause: clogged filters/fittings work performed: cleared the clogged filters/fittings solution: cleared the clogged filters/fittings parts replaced: 338154 ¿ spaii wash station barbed fitting returned sample analysis: there were no defective parts.Manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: risk management file part #100245ra, revision 03 was reviewed.Hazard(s) identified? yes.No.Hazard id: 3.1.29.Hazard: environment biohazard cause: filter/components in fluid path get clogged, wash station backs up due to waste pump failure harmful effects: exposure to biohazard residual severity: 5 residual probability: 1 residual risk index: 5 potential causes: based on the investigation result and fse¿s report the potential cause was determined to be the clogged filter/fittings.Conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for continuous flooding of instrument.No one was harmed or injured, and no medical diagnosis was performed due to any incorrect results.There was no impact to the patient health or safety.

Event Description

It was reported that bd facs¿ sample prep assistant iii continuous flooding of instrument has occurred after several cleanings.The following information was provided by the initial reporter: continuous flooding of instrument, even after multiple filter cleanings occurred.The leak appears to be a biohazard liquid.The leakage did not come in contact to personnel and no injuries were reported.

• Brand Name: BD FACS¿ SAMPLE PREP ASSISTANT III
• Type of Device: SEE H.10.
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16000045
• MDR Text Key: 308487845
• Report Number: 2916837-2022-00367
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

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 Model Number: 647205
• Device Catalogue Number: 647205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• 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