MAUDE Adverse Event Report: XVIVO PERFUSION AB XVIVO ORGAN CHAMBER

Model Number	19020
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Malfunction according to the reporter three devices with unsealed sterile barrier were found at user facility quality inspection when receiving the goods.

• Brand Name: XVIVO ORGAN CHAMBER
• Common Device Name: ORGAN CHAMBER
• Manufacturer (Section D): XVIVO PERFUSION AB; massans gata 10; goteborg, ; SW
• Manufacturer (Section G): IPAX INC; 2700 s raritan street; englewood CO 80110
• Manufacturer Contact: katrin gisselfalt ; massans gata 10; goteborg, 41251 ; SW 41251
• MDR Report Key: 14140108
• Report Number: 3007710603-2022-00001
• Device Sequence Number: 17319903
• Product Code: PHO
• UDI-Device Identifier: 07350069520074
• UDI-Public: 07350069520074
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 19020
• Device Catalogue Number: 19020
• Device Lot Number: 13801
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/19/2022
• 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