MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-19 for SPS-1 STATIC PRESERVATION SOLUTION manufactured by Organ Recovery Systems, Inc..
[62696545]
Patient Sequence No: 1, Text Type: N, H10
[62696546]
A liver transplant recipient anesthetized on table. When the sterile bag containing the liver was opened, the transplant surgeon immediately noted a foul odor (later became even more potent) and the case was ceased until the source of the odor could be determined. Case subsequently cancelled as cause of odor determined to be coming from at least two bags of organ preservation fluid. Samples of fluid were taken and sent to microbiology; results came back positive for a number of organisms. Preliminary results showed the following: sample [1] is original sample, directly out of bag perfusing one of the kidneys. Growth is abundant. Preliminary identifications so far are for enterococcus casseliflavus and pantoea agglomerans. Sample [2] is "sps straight out of bag into jar", and it looks clean by gram stain. Sample [3] is "sps from jar w/lt kidney" and has a gram stain similar to the original one from yesterday (mixed organisms, abundant). Sample [4] is "sps lot pbr 0060 392". Gram-positive cocci that are similar to those previously; for whatever reason they're more sparse and the gram negative organisms are not here but may appear later in culture. Sample [5] is "sps lot pbr 0074 330". This appeared clean by gram stain at the time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6184847 |
| MDR Report Key | 6184847 |
| Date Received | 2016-12-19 |
| Date of Report | 2016-12-13 |
| Date of Event | 2016-12-12 |
| Report Date | 2016-12-13 |
| Date Reported to FDA | 2016-12-13 |
| Date Reported to Mfgr | 2016-12-13 |
| Date Added to Maude | 2016-12-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPS-1 STATIC PRESERVATION SOLUTION |
| Generic Name | SYSTEM, PERFUSION, KIDNEY |
| Product Code | KDL |
| Date Received | 2016-12-19 |
| Lot Number | PBR0074330 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| 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 | 2016-12-19 |