MAUDE Adverse Event Report: XVIVO PERFUSION AB PERFADEX + THAM SOLUTION; COLD PRESERVATION SOLUTION

Model Number	19018
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was not an adverse event nor was the product malfunctioning.The device was damaged during use.[customer medwatch report mw5077650.Pdf].
Event or Problem Description
This information was provided by the customer to the fda in a voluntary medwatch report (mw5077650) dated (b)(6) 2018."physicians and procurement staff were involved in a lung recovery.The perfadex preservation solution was transported to the facility in a cooler.One bag of solution was infused during the recovery and a second bag was prepped for infusion after the lungs were recovered.After approximately half of the fluid was infused from the second bag, a small hole was discovered in the top portion of the bag.The recovery surgeons were informed about the incident as well as the transplanting surgeon and the decision was made to continue with the procedure.The hole was very small and only a small stream of fluid leaked from the bag when pressure was applied.A report was filed with the (b)(4).Mfr (xvivo perfusion) has been contacted (and responded quickly) as well.Although the manufacturer denied any current recall notices (i had also verified recalls on the fda site), they did state that as of 2018, they have a new bag design that will hopefully eliminate future incidents.We will continue to monitor the patient closely.At present, the patient is recovering without incident.Suspect: yes; primary: yes; product type: drug/biologic.Dose or amount: 2800 ml, frequency: 1 time, route: intravenous.Strength: na ml.Therapy duration: 20 years.Reason for use: lung preservation during organ recovery." xvivo perfusion has determined that no mdr is required as this device was damaged during procedure by applying pressure to the bag and there were no serious event related to this.However we wanted to acknowledge the receipt of the medwatch report from the customer.

• Brand Name: PERFADEX + THAM SOLUTION
• Common Device Name: COLD PRESERVATION SOLUTION
• Manufacturer (Section D): XVIVO PERFUSION AB; massans gata 10; goteborg, 41251 ; SW 41251
• MDR Report Key: 7650347
• Report Number: 3007710603-2018-00001
• Device Sequence Number: 1550798
• Product Code: KDN
• UDI-Device Identifier: 07350069520067
• UDI-Public: 07350069520067
• Combination Product (Y/N): N
• PMA/510(K) Number: K091989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2018

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: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: 19018
• Device Catalogue Number: 19018
• Device Lot Number: 600148
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2018
• Initial Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1