MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-01 for SPS STATIC PRESERVATION SOLUTION manufactured by Organ Recovery Systems, Inc..
[66264317]
Patient Sequence No: 1, Text Type: N, H10
[66264318]
Elderly gentleman with treacher collins, well controlled (b)(6) infection and a history of esrd now status post deceased donor kidney transplantation (thymo induction, on mmf/tacrolimus/prednisone) complicated by urinary retention, urinary tract infection (uti) and clostridium difficile infection. He was more recently admitted with escherichia coli (e coli) bacteremia. Ct showed findings potentially consistent with emphysematous pyelonephritis and a 1. 1cm low attenuation nodule on the prostate and presumed wedge spleen infarct with evidence of splenic granulomas as possible sources. Ct cystogram showed no fistula. He clinically improved on cefepime with plans for two further weeks of levofloxacin given the prostate abnormality and outpatient luminal gi exploration as a source of infection. Diagnosis made based on uti and positive blood cultures. Urine and blood cultures (1 of 4) positive for e. Coli. Also ct scan performed. Noted when recall communicated previously: organ recovery systems ("ors") has issued a recall for two additional lots of sps static preservation solution? ("sps"), lot #'s pbr-0074-337 and pbr-0060-386. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[67884091]
Patient Sequence No: 1, Text Type: N, H10
[67884092]
Elderly gentleman with treacher collins, well controlled (b)(6) infections and a history of esrd now status post deceased donor kidney transplantation (thymo induction, on mmf/tacrolimus/prednisone) complicated by urinary retention, urinary tract infection (uti) and clostridium difficile infection. He was more recently admitted with escherichia coli (e coli) bacteremia. Ct showed findings potentially consistent with emphysematous pyelonephritis and a 1. 1cm low attenuation nodule on the prostate and presumed wedge spleen infarct with evidence of splenic granulomas as possible sources. Ct cystogram showed no fistula. He clinically improved on cefepime with plans for two further weeks of levofloxacin given the prostate abnormality and outpatient luminal gi exploration as a source of infection. Diagnosis made based on uti and positive blood cultures. Urine and blood cultures (1 of 4) positive for e. Coli. Also ct scan performed (as above). Noted when recall communicated previously: (b)(4) has issued a recall for two additional lots of sps static preservation solution? ("sps"), lot #'s pbr-0074-337 and pbr-0060-386. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6292203 |
| MDR Report Key | 6292203 |
| Date Received | 2017-02-01 |
| Date of Report | 2017-01-20 |
| Date of Event | 2017-01-13 |
| Report Date | 2017-01-18 |
| Date Reported to FDA | 2017-01-18 |
| Date Reported to Mfgr | 2017-01-18 |
| Date Added to Maude | 2017-02-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 STATIC PRESERVATION SOLUTION |
| Generic Name | SET, PERFUSION, KIDNEY, DISPOSABLE |
| Product Code | KDL |
| Date Received | 2017-02-01 |
| Lot Number | PBR-0074-337 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEMS, INC. |
| Manufacturer Address | 1 PIERCE PLACE SUITE 475W ITASCA IL 60143 US 60143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-01 |