MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SMARTPUMP DUAL CHANNEL; TOURNIQUET, PNEUMATIC

Catalog Number	5920011000
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Codes	Erythema (1840); Swelling/ Edema (4577)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after removing the tourniquet in the operating room, it was noted that the patient's skin was warm, dry, and blanchable.When the skin assessment was completed in the post anesthesia care unit, the registered nurse inspected the right lower extremity and noted that the patient had circumferential swelling in the right thigh at the tourniquet site with redness and blanchable.It was further reported that the patient suffered erythema and swelling/ edema as well as developing compartment syndrome, which required a fasciotomy.Further attempts are being made to obtain information regarding the injuries.
Event or Problem Description
It was reported that after removing the tourniquet in the operating room, it was noted that the patient's skin was warm, dry, and blanchable.When the skin assessment was completed in the post anesthesia care unit, the registered nurse inspected the right lower extremity and noted that the patient had circumferential swelling in the right thigh at the tourniquet site with redness and blanchable.It was further reported that the patient suffered erythema and swelling/ edema as well as developing compartment syndrome, which required a fasciotomy.There was no delay in the procedure as the device was used in the primary case, and the complication of the compartment syndrome was diagnosed post-operatively.Appropriate interventions were performed without delay.
Additional Manufacturer Narrative
Correction: d9; h3.The device was not returned for evaluation; therefore, a root cause could not be determined for the event.

• Brand Name: SMARTPUMP DUAL CHANNEL
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 20175793
• Report Number: 3015967359-2024-01778
• Device Sequence Number: 8196492
• Product Code: KCY
• UDI-Device Identifier: 07613154589647
• UDI-Public: (01)07613154589647(21)2011603383
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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 Catalogue Number: 5920011000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown