MAUDE Adverse Event Report: Medline Industries, LP CENTURION; WEEKLY LVAD TRAY

Catalog Number	DM100
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we had a customer receive some dm100 kits with dry sorbaview that would not stick." "all 24 kits received were impacted.".
Additional Manufacturer Narrative
The account reported finding sorbaview dried out, and the complaint text reported dry sorbaview that would not stick with all 24 kits received impacted.No sample or photo was received for the investigation; finished good production records were reviewed and found no nonconformances noted by production or quality control personnel during first article, in-process, or case packaging inspections, and the bom for kit dm100 was reviewed and no issues were identified.The reported issue could not be evaluated because the investigation was limited without a sample and no component or kit inventory from the affected lot remained in inventory for evaluation.At this time, the root cause cannot be determined; review of centurion's complaint history did not find any similar reports of adhesion issues with component sv37, therefore this issue appears to be isolated at this time, and this issue will continue to be monitored by centurion's complaint system.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: CENTURION
• Common Device Name: WEEKLY LVAD TRAY
• Manufacturer (Section D): Medline Industries, LP; 301 catrell drive; howell MI 48843
• Manufacturer Contact: kim evangelista ; 301 catrell drive; howell, MI 48843
• MDR Report Key: 50713809
• Report Number: 1824619-2026-00043
• Device Sequence Number: 10696192
• Product Code: OXQ
• UDI-Device Identifier: 10653160280101
• UDI-Public: 10653160280101
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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 Catalogue Number: DM100
• Device Lot Number: 2024011190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown