ORGAN PRESERVATION SOLUTIONS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-21 for ORGAN PRESERVATION SOLUTIONS manufactured by Organ Recovery Systems.

Event Text Entries

[63133793] A notice was sent by unos informing transplant centers of a recent recall involving organ flush solutions. A transplant recipient at (b)(6) received a liver that had been flushed with the recalled solution, "the organ preservation solution, sps-1, is manufactured by organ recovery systems (ors). Bags with microbial growth were reported from two lots. " according to the mfr (organ recovery systems), the initial recall resulted from an "uncharacteristic odor" from one of two potential lot numbers indicating potential contamination. We only have one recipient impacted by the recall thus far but are continuing to investigate and determine whether other recipients may be involved. The mfr has not reported any adverse events to date. Our facility does not stock or use the solution referenced in the recall but we are prone to receiving organs that may be transported from other organ procurement organizations. Therapy start date: (b)(6) 2016. Therapy end date: (b)(6) 2016. Organ preservation/transport. Is the product compounded: yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5066870
• MDR Report Key: 6199787
• Date Received: 2016-12-21
• Date of Report: 2016-12-21
• Date of Event: 2016-11-16
• 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
• 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: ORGAN PRESERVATION SOLUTIONS
• Generic Name: ORGAN PRESERVATION SOLUTIONS
• Product Code: KDL
• Date Received: 2016-12-21
• 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

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2016-12-21