MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION FlexiPort Disposable Blood Pressure Cuff; SOFT-11

Model Number	SOFT-11
Medical Device Problem Codes	Material Deformation (2976); Inaccurate Information (4051); Failure to Deflate (4060)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported concerns regarding the accuracy of non-invasive blood pressure (nibp) measurements obtained using disposable flexiport soft cuffs.Three days later, the customer provided the following additional information.Reportedly, a patient lost pulses at approximately 0930 and underwent resuscitation efforts.Following placement of an arterial line after the resuscitation, a discrepancy was observed between non-invasive blood pressure (nibp) cuff readings and arterial line pressure measurements.According to the report, the blood pressure cuff on the patient's arm consistently displayed measurements that were substantially lower than the arterial line readings.As an example, at approximately 1800, the blood pressure cuff reportedly displayed a reading of 64/41 mmhg while the arterial line reading was 105/53 mmhg.The customer further reported that at 1000, 1015, and 1100, the blood pressure cuff continued to display extremely low blood pressure readings when the cuff was not secured around the patient's arm and was reportedly positioned underneath the patient.The customer reported concern that the discrepancy between the nibp cuff readings and arterial line pressure measurements may have impacted the interpretation of the patient's blood pressure status.Furthermore, the customer reported that hospital staff had raised additional concerns regarding the disposable flexiport soft cuffs, including cuffs sliding down, retaining air, causing patient discomfort, and clips detaching during blood pressure measurements.The bp cuff involved in this case was returned for inspection.It is unclear which monitoring device was used with the reported bp cuff; however, it is noted that the facility predominantly employs non-baxter monitors.Additional information regarding the reported events were requested.Investigation is ongoing.
Additional Manufacturer Narrative
Flexiport pediatric through adult reusable blood pressure cuffs are noninvasive blood pressure cuffs intended for use in conjunction with non-automated and automated sphygmomanometers to determine blood pressure in pediatric through adult patients.An inspection of the device performed by a baxter technician was unable to verify the reported issues of inaccurate blood pressure readings or failure to deflate.The device passed functional testing and blood pressure accuracy testing.Visual inspection identified wear and tear of the cuff velcro.No further issues were identified.In this event, it was reported that the patient lost pulses and required resuscitation.This represents a life-threatening condition requiring immediate medical intervention and is therefore considered a serious injury.The customer subsequently identified a discrepancy between nibp cuff measurements and arterial line pressure readings, with the nibp readings reportedly being substantially lower than the arterial line readings.The exact cause of the reported discrepancy is undetermined at this time.An inspection of the returned device was unable to replicate the report of inaccurate readings, and the device passed all functional and accuracy testing.Additionally, it is unclear which monitoring device was used with the reported cuff during the event.Therefore, a potential contribution of the monitoring system to the reported discrepancy cannot be excluded.Based on the available information, a causal relationship between the reported device and the serious injury cannot be determined.Further investigation is on-going, if any additional and relevant information is received, it will be submitted in a supplemental report.

• Brand Name: FlexiPort Disposable Blood Pressure Cuff
• Common Device Name: SOFT-11
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): WELCH ALLYN PRODUCTS, MEXICO; emilio flores #2471-a2; caã¿â¿¿on del padre; tijuana, baja california NA 22203 ; MX 22203
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50753166
• Report Number: 3006087789-2026-00023
• Device Sequence Number: 9668013
• Product Code: DXQ
• UDI-Device Identifier: 00732094188097
• UDI-Public: 00732094188097
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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 Model Number: SOFT-11
• Device Catalogue Number: SOFT-11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown