MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; EVLP PACK

Model Number	DYNJ901205C
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that expired 0.9% sodium chloride in the evlp pack was used in clinical procedures for lungs that were transplanted into a patient.Approximately 6-12 hours prior to transplant 50ml of the 0.9% sodium chloride was used as part of a pressure monitoring function.The 0.9% sodium chloride is part of medline's custom pack/kit.The evlp pack was released for use based upon the pack expiration date.The expired saline within the released pack was discovered by one of the facility technicians noticing the expiration date at the time of use on a separate occasion.Verification of individual expiration dates of pack components was not part of the facility's quality control procedures at the time of this event.No side effects have been reported to the manufacturer for the patient that has received the lung exposed to the expired saline.No serious injury has been identified, medical intervention required and no follow up medical care was needed after the transplant.After the issue was noticed the remainder of the expired material was pulled from the facilities shelves and quarantined.No additional information is available.The sample has not been returned to the manufacturer for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that expired 0.9% sodium chloride in the evlp pack was used in clinical procedures for lungs that were transplanted into a patient.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: EVLP PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12647364
• Report Number: 1423395-2021-00053
• Device Sequence Number: 17265536
• Product Code: LRO
• UDI-Device Identifier: 10889942580606
• UDI-Public: 10889942580606
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNJ901205C
• Device Catalogue Number: DYNJ901205C
• Device Lot Number: 19HBE998
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other