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 2017-12-28 for SPS-1 manufactured by Organ Recovery Systems, Inc..

Event Text Entries

[96179618] I donated a kidney to my mom in (b)(6) 2016. She got a fever of unknown origin that was finally contributed to an subcutaneous abscess around her new kidney. She has gone 10 plus months with zero help issues (relatively speaking), but this month is like someone hit repeat. During my mom's 3 month check up she was informed of the possibility a contaminated batch of organ preservation fluid had been used during her procedure. This was followed by a letter that pretty much said nothing. I have followed the bread crumbs and realized that the bacteria had been identified in the lots of contaminated solutions and they just so happen to be locked in an abscess around my mom's new organ. I have scoured the internet looking for information or similar situations but all that is found are the official reports. The incident is not even being discussed on the blogs or in the forums. I would just really like to know how to find out what hospitals had the solutions in the lots... If mom's surgery hospital is on the list i would like to know if one was used on her organ. I am merely a daughter, sister, mother, organ donor searching for answers in hopes of finding solutions. How is someone supposed to report a related infection if they cannot find out the lot number of the solution used to transport the organ? Global solution system.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5074288
MDR Report Key7154414
Date Received2017-12-28
Date of Report2017-12-22
Date of Event2016-10-16
Date Added to Maude2017-12-29
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
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 Report0

Device Details

Brand NameSPS-1
Generic NameSPS-1
Product CodeKDN
Date Received2017-12-28
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerORGAN RECOVERY SYSTEMS, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2017-12-28

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