SPS-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-30 for SPS-1 manufactured by Organ Recovery Systems Inc.

Event Text Entries

[66062521]
Patient Sequence No: 1, Text Type: N, H10


[66062522] Transplant administration received an email from our organ procurement agency that our recipient received a liver graft that was perfused with a recalled batch of organ preservation solution. We were made aware of a voluntary recall on certain batches of organ preservation solution called static preservation solution -1 (sps-1), manufactured by organ recovery systems. The recall was due to a report by another opo regarding bacterial contamination. According to the report the solution samples obtained from several opened bags were positive for pantoea agglomerans and enterococcus casseliflavus. This microbial growth was reported for two lots of the preservation solution sps-1. Lots: pbr-0060-386. Our pharmacy was made aware of the recall shortly after we received notice from the first opo over the weekend. Pharmacy and the operating room immediately quarantined any unused inventory from the affected lots. The patient is at home and is afebrile. At the recommendation of our id team we will be obtaining one set of blood cultures on this recipient at their next blood draw.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6285499
MDR Report Key6285499
Date Received2017-01-30
Date of Report2017-01-27
Date of Event2016-09-18
Report Date2017-01-27
Date Reported to FDA2017-01-27
Date Reported to Mfgr2017-01-27
Date Added to Maude2017-01-30
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPS-1
Generic NameORGAN PRESERVATION SOLUTION
Product CodeKDL
Date Received2017-01-30
Lot NumberPBR-0060-386
OperatorPHYSICIAN
Device Availability*
Device Age1 DY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerORGAN RECOVERY SYSTEMS INC
Manufacturer AddressONE PIERCE PLACE SUITE 475W ITASCA IL 60143 US 60143


Patients

Patient NumberTreatmentOutcomeDate
10 2017-01-30

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