MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-10 for SPS-1 STATIC PRESERVATION SOLUTION SPS-1_2L manufactured by Organ Recovery Systems, Inc.
[67594522]
Investigation of this issue and the recall activities for these lots are in progress. Fda will be notified upon additional information available.
Patient Sequence No: 1, Text Type: N, H10
[67594523]
Four complaints were received from customers who observed a "strange odor" "emanating from the solution" from sps-1 (static preservation solution) solution bags and the solution itself. Related ors(organ recovery systems, inc. ) complaint numbers: rma-002039, rma-002080, rma-002144, rma-002150. Lots involved: sps-1_1l: pbr-0060-392, sps-1_1l: pbr-0060-386. Sps-1_2l: pbr-0074-330, sps-1_2l: pbr-0074-337. In cases where the 1l and 2l were included in the complaint, the customers weren't sure which bag the odor was coming from. After initial investigation it is confirmed that the device is malfunctioned. Complaints were determined to be potentially reportable. Ors management decided to initiate a voluntary product recall in parallel with the investigation. The fda (b)(4) office and fda (b)(4) office was notified of the initial actions for lots pbr-0060-392 and pbr-0074-330 on (b)(6) 2016. Communication with the fda continued throughout the investigation as the additional complaints were received and additional actions taken. Date complaint received for lot pbr-00674-337: (b)(6) 2017. Fda recall number: z-1111-2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004068499-2017-00004 |
| MDR Report Key | 6324309 |
| Date Received | 2017-02-10 |
| Date of Report | 2017-02-10 |
| Date of Event | 2017-01-08 |
| Date Mfgr Received | 2017-01-11 |
| Device Manufacturer Date | 2016-09-15 |
| Date Added to Maude | 2017-02-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PJ PARDO |
| Manufacturer Street | ONE PIERCE PLACE SUITE 475W |
| Manufacturer City | ITASCA IL 60143 |
| Manufacturer Country | US |
| Manufacturer Postal | 60143 |
| Manufacturer Phone | 8478242600 |
| Manufacturer G1 | ORGAN RECOVERY SYSTEMS, INC |
| Manufacturer Street | ONE PIERCE PLACE SUITE 475W |
| Manufacturer City | ITASCA IL 60143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1111-2017 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPS-1 STATIC PRESERVATION SOLUTION |
| Generic Name | SPS-1 (UW SOLUTION) |
| Product Code | KDN |
| Date Received | 2017-02-10 |
| Model Number | SPS-1_2L |
| Catalog Number | SPS-1_2L |
| Lot Number | PBR-0074-337 |
| Device Expiration Date | 2018-09-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEMS, INC |
| Manufacturer Address | ONE PIERCE PLACE SUITE 475W ITASCA IL 60143 US 60143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-10 |