MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; PRESSUREPLUS INFUSION BAG, 500ML

Catalog Number	DYNJPI500C
Medical Device Problem Codes	False Positive Result (1227); Unintended Deflation (4061)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, "the pressure bag had deflated" leading to "false data." the customer reported that the clinician began treating the patient for hypotension by titrating "vasopressors based off of the arterial bp." per the customer, "investigation revealed that the pressure bag had deflated" and the "pressors rapidly titrated down." the customer reported "no new treatments were needed post event." the customer stated "although team members reported that the stopcock was turned upward toward the bag and the clamp was closed, i am not certain this was consistently the case." the customer said "no additional occurrences have been reported after the team was instructed to ensure the stopcock is turned toward the bag" and "these events may have been related more to user error than to supply or equipment issues." no additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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
According to the customer, "the pressure bag had deflated" leading to "false data." the customer reported that the clinician began treating the patient for hypotension by titrating "vasopressors based off of the arterial bp." per the customer, "investigation revealed that the pressure bag had deflated" and the "pressors rapidly titrated down.".

• Brand Name: MEDLINE
• Common Device Name: PRESSUREPLUS INFUSION BAG, 500ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24326243
• Report Number: 1417592-2026-00113
• Device Sequence Number: 21201223
• Product Code: KZD
• UDI-Device Identifier: 10193489033113
• UDI-Public: 10193489033113
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJPI500C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown