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 2017-02-03 for SPS-1 manufactured by Organ Recovery Systems.

Event Text Entries

[66676058] This is a pt that received a deceased donor transplant on (b)(6) 2016 and had a fungal infection that required explant of the transplanted organ in (b)(6) 2016. Our center recently received notification from unos regarding a contaminated sps solution that applies to this case. This is the notification received: this is an update to an epi-x posted on (b)(6) 2017, which reported potential bacterial contamination in sps-1 lots pbr-0074-337, pbr-0060-386, pbr-0074-330, and pbr-0060-392. Fda's investigation of potential contamination of several lots of sps-1, manufactured by organ recovery systems (ors) is ongoing. We recommend that organ procurement organizations (opo) and transplant facilities should consider transitioning to alternate, fda-cleared organ preservation fluid products from other mfrs. " please take the following actions to report adverse events occurring on or after (b)(6) 2016, in pts who received organs or tissues from organ recovery procedures using sps-1 from any manufacturing lot file a report with fda's medwatch safety info and adverse event reporting. Therapy start date: (b)(6) 2016. Therapy end date: (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5067678
• MDR Report Key: 6303625
• Date Received: 2017-02-03
• Date of Report: 2017-02-02
• Date of Event: 2016-04-19
• Date Added to Maude: 2017-02-06
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• 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 Details

• Brand Name: SPS-1
• Generic Name: SPS-1
• Product Code: KDL
• Date Received: 2017-02-03
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ORGAN RECOVERY SYSTEMS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Deathisabilit	2017-02-03