SPS-1 (HTTP://WWW.ORG-AN-RECOVERY)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-22 for SPS-1 (HTTP://WWW.ORG-AN-RECOVERY) manufactured by Organ Recovery Systems.

Event Text Entries

[63170936] The pt received a kidney and pancreas transplant at (b)(6) from a donor recovered by (b)(6) using a preservation solution subsequently recalled by the fda for possible bacterial contamination: sps-1 (http://www. Organ-recovery. Com). Pbr-0074-330, expiration 07/01/2018; pbr-0060-392, expiration 06/01/2018. The pt developed a febrile illness marked by a leukocytosis of 30,000. Multiple cultures of different body fluids were negative, but the pt was on broad spectrum antibiotics. She has subsequently done well but had a difficult 20 day hospitalization and required reoperation after the initial transplant operation. Therapy start date: (b)(6) 2016. Therapy end date: (b)(6) 2016. Diagnosis or reason for use: organ recovery. Event abated after use stopped or dose reduced? Yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5066872
• MDR Report Key: 6199789
• Date Received: 2016-12-22
• Date of Report: 2016-12-21
• Date of Event: 2016-11-19
• Date Added to Maude: 2016-12-22
• Event Key: 0
• Report Source Code: Voluntary 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

Device Sequence Number: 1

• Brand Name: SPS-1 (HTTP://WWW.ORG-AN-RECOVERY)
• Generic Name: STATIC PRESERVATION SOLUTION
• Product Code: KDL
• Date Received: 2016-12-22
• Lot Number: PBR-0074-330
• Device Expiration Date: 2018-07-01
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ORGAN RECOVERY SYSTEMS

Device Sequence Number: 2

• Brand Name: SPS-1 (HTTP://WWW.ORG-AN-RECOVERY)
• Generic Name: STATIC PRESERVATION SOLUTION
• Product Code: KDL
• Date Received: 2016-12-22
• Lot Number: PBR-0060-392
• Device Expiration Date: 2018-06-01
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ORGAN RECOVERY SYSTEMS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2016-12-22