MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. VP2000 PROCESSOR; STAINER, TISSUE, AUTOMATED

Model Number	02J11-001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Elevated complaint investigation will be initiated.
Event or Problem Description
Customer reported seeing wet surface under the vp2000 instrument on the countertop.The customer determined that the leak was coming from below the rinse tank.The water leak ran down from top of the counter down along the cabinet front and on to the floor.The leak was small and contained on the floor under the cabinet towards the front.No exposure or injury related to the leak.The customer was wearing personal protective equipment (ppe) and cleaned the wet spots on the countertop and under cabinet floor.The customer reported they stopped using the instrument.Although the customer reported the leak was underneath the cabinet floor, this form will be run as worst case scenario that the leak had reached the walking surface.The customer was not able to provide additional pictures of the extent of the leak.
Additional Manufacturer Narrative
Investigation into this complaint included a customer data review, customer file review, quality data review, and a complaint history review.The results of the investigation are summarized as follows: product/system/instrument evaluation service history review vp2000 serial number (sn) (b)(6), was installed at a customer site in houston, texas, usa.A review of all service tickets for this instrument system was performed to identify any additional tickets that were related to evidence of leaking from the rinse tank.This review only identified current complaint ticket under investigation.Customer data review: activity text provided in the elevated complaint ticket were reviewed.Customer reported seeing wet surface under the instrument on the countertop during protocol run.Customer determined leak coming from below the rinse tank.The customer was wearing ppe and cleaned the wet spots on the countertop and under cabinet floor.Customer stopped using the instrument.The fse concluded the leak came from loose tubing and the rinse tank assembly was replaced.No exposure or injury related to the leak were reported.Quality data review: capa / non-conformance review: a search of non-conformance (nc) and capa (nc/capa) records was performed for instances related to the abbott vp 2000¿ processor base list number (ln) 02j11 and vp2000 rinse tank assy part number (pn) 30-144140.The query for all existing nonconformance / capa records for the abbott vp 2000¿ processor (base ln 021j11) and the rinse tank assy (pn 30-144140) did not identify any related records associated with the reported issue under investigation.Complaint history review: a complaint search was performed to identify past complaint tickets for any instances of a potential reportable event (pre) involving a leak of the abbott vp 2000¿ processor (based list number (ln) 02j11) rinse tank assy (part number (pn) 30-144140).Complaint history review did not identify any additional related complaints.Based on the results of the investigation, no product deficiency was identified for the vys vp2000, 117v, ln 02j11-01, sn (b)(6).

• Brand Name: VP2000 PROCESSOR
• Common Device Name: STAINER, TISSUE, AUTOMATED
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018-3315 ; 2242064064
• MDR Report Key: 16477845
• Report Number: 3005248192-2023-00119
• Device Sequence Number: 3150514
• Product Code: KEY
• UDI-Device Identifier: 00884999001916
• UDI-Public: 00884999001916
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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 Model Number: 02J11-001
• Device Catalogue Number: 02J11-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown