MAUDE Adverse Event Report: MANAMED PLASMAFLOW; SLEEVE, LIMB, COMPRESSIBLE

Model Number	PF0001
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 24-aug-2023, manamed received notification of report mw5120348 via medwatch.The following problem description was provided in that report: "plasmaflow scd, (sequential device) on patients left lower extremity failed to deflate for the entire six hour 50 minute procedure.This was discovered in post op after patient awoke and mentioned left calf pain.Scd was turned off but remained inflated.Scd was removed and patient was assessed by anesthesia md and nursing team.Out of abundance of caution patient was transferred to acute care hospital emergency department to rule out compartment syndrome.Refer to additional documents in i2k." the original report claimed a serious injury and cited the health effect as 1994: pain.Despite repeated requests, the original reporting party has refused to return the device, allow analysis of the device, or allow us to interview witnesses to the event.We are therefore unable to confirm or reproduce the reported error, or to perform any meaningful investigation into its cause.Although we do not have additional information at this time, we are submitting this report as required by 21 cfr part 803.
Additional Manufacturer Narrative
Despite repeated requests, the original reporting party has refused to return the device, allow analysis of the device, or allow us to interview witnesses to the event.We are therefore unable to confirm or reproduce the reported error, or to perform any meaningful investigation into its cause.
Additional Manufacturer Narrative
Udi related data quality updates.Actual complaint unit was observed at clinic and although the device was void of air after deflation, the unit read greater than zero pressure in device.

• Brand Name: PLASMAFLOW
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): MANAMED; 2612 sirius dr; denton TX 76208
• Manufacturer Contact: john beasley ; 2612 sirius dr; denton, TX 76208
• MDR Report Key: 17914549
• Report Number: 3011767724-2023-00001
• Device Sequence Number: 7472686
• Product Code: JOW
• UDI-Device Identifier: 00850998008003
• UDI-Public: (01)00850998008003(10)PO101134(21)PF23001895
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: PF0001
• Device Catalogue Number: PF0001
• Device Lot Number: PO101134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown