MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ABBOTT M2000SP INSTRUMENT; CLINICAL SAMPLE CONCENTRATOR

Catalog Number	09K14-02
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An elevated complaint investigation will be performed.This incident is being reported to fda because the incident occurred in (b)(6) using the m2000sp instrument, list number 09k14-02 which is also approved for use in the united states.
Event or Problem Description
The customer reported fluid leakage from the m2000sp instrument.The leak occurred while the instrument was performing an extensive flush during a maintenance procedure.The fluid dripped inside the solid waste container.When opening the waste drawer, a small patch of liquid reached the walking surface.The customer was wearing personal protective equipment (ppe), and they did not come in direct contact with the liquid.There was no injury reported related to the event.The field service engineer (fse) reported that the hose clip fastening the waste tube was loose allowing fluid to pass out of the tube.The clip also showed extensive corrosion, and the waste tube was discolored.The waste tubing was replaced with a new hose clip.All verifications performed and passed.This incident is being reported to fda because the incident occurred in (b)(6) using the m2000sp instrument, list number 09k14-02 which is also approved for use in the united states.
Additional Manufacturer Narrative
Investigation into this complaint included a quality data review, product/system/instrument evaluation and a complaint history review.Investigation is summarized as follows: quality data review: two capa/nonconformance searches were performed for any related capa investigations for the m2000sp e-series instrument list number 9k14-02 or the tube waste tygon 9.6*12.8mm 2500mm part number 30098435 and found no related entries.Product/system/instrument evaluation: service history review revealed m2000sp sn (serial number) 11480 was installed at the complaint customer site in 2018.Review of all service tickets for this instrument system found only this complaint ticket under investigation was related to liquid waste leaking onto the floor.Customer data review: activity comment text summarized the customer called to report the liquid waste was dripping from the tubing during an extensive flush during daily maintenance.A leak was found at the y-connector because the hose clamp was loose.Because the clip had extensive corrosion the liquid waste tubing and hose clamp were replaced.No further action was required.An attached video of the leak was reviewed.Replacement of the liquid waste tubing and hose clamp stopped the leaking and no further action was required.A video of the fluid leak was attached to the complaint ticket.An email from service personnel estimated the 100 to 200ml of liquid waste was mopped-up from the floor after the drawer-pull spill.The customer cleaned-up approximately 100ml from the floor.Complaint history review: complaint history review identified one additional ticket related to liquid dripping on the floor for the m2000sp instrument within the last 2 years; however the ticket was individually investigated and was attributed to a different cause.Based on the results of this investigation, no product deficiency for the m2000sp instrument base list number 9k14 or the liquid waste tubing part number 30098435 was identified.

• Brand Name: ABBOTT M2000SP INSTRUMENT
• Common Device Name: CLINICAL SAMPLE CONCENTRATOR
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• MDR Report Key: 8843380
• Report Number: 3005248192-2019-00006
• Device Sequence Number: 10835282
• Product Code: JJH
• UDI-Device Identifier: 00884999031753
• UDI-Public: 00884999031753
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• PMA/510(K) Number: K092705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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
• Operator of Device: No Information
• Device Catalogue Number: 09K14-02
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1