MAUDE Adverse Event Report: XVIVO PERFUSION AB XVIVO ORGAN CHAMBER

Model Number 19020

Device Problem Unsealed Device Packaging (1444)

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

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 298951765
• Report Number: 3007710603-2022-00001
• Device Sequence Number: 1
• Product Code: PHO
• UDI-Device Identifier: 07350069520074
• UDI-Public: 07350069520074
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 19020
• Device Catalogue Number: 19020
• Device Lot Number: 13801
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1