MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-29 for PERFADEX + THAM SOLUTION 19018 manufactured by Xvivo Perfusion Ab.
[113165691]
This event was not an adverse event nor was the product malfunctioning. The device was damaged during use. [customer medwatch report mw5077650. Pdf].
Patient Sequence No: 1, Text Type: N, H10
[113165692]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007710603-2018-00001 |
| MDR Report Key | 7650347 |
| Date Received | 2018-06-29 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-05-30 |
| Date Mfgr Received | 2018-05-19 |
| Date Added to Maude | 2018-06-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS ANNA WENNERBERG |
| Manufacturer Street | MASSANS GATA 10 |
| Manufacturer City | GOTEBORG, 41251 |
| Manufacturer Country | SW |
| Manufacturer Postal | 41251 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PERFADEX + THAM SOLUTION |
| Generic Name | COLD PRESERVATION SOLUTION |
| Product Code | KDN |
| Date Received | 2018-06-29 |
| Model Number | 19018 |
| Catalog Number | 19018 |
| Lot Number | 600148 |
| Device Expiration Date | 2019-05-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XVIVO PERFUSION AB |
| Manufacturer Address | MASSANS GATA 10 GOTEBORG, 41251 SW 41251 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-29 |