MAUDE Adverse Event Report: CARDINAL HEALTH SCD 700 COMPRESSION SYSTEM-BRZ; SLEEVE, LIMB, COMPRESSIBLE

Model Number 295258

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 07/03/2023

Event Type  Injury  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that the patient developed a thrombosis while using the device.There was no error notification with the compressor.No problem was noticed with the leggings.Additional information was received stating that the patient required anticoagulation medication and local application of heat/cold therapy and/or topical medications.The patient was in a debilitated condition prior to the use of the device.There was no redness or tenderness observed.No further information was provided.

Manufacturer Narrative

The epump was collected from the customer, and service was performed.The compressor was tested and passed.The reported condition could not be duplicated.A performance certification was done, and the unit passed all testing with no deviations.The device will be released for use.This complaint will be used for tracking and trending purposes.

• Brand Name: SCD 700 COMPRESSION SYSTEM-BRZ
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17305205
• MDR Text Key: 318925062
• Report Number: 1282497-2023-10765
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 295258
• Device Catalogue Number: 295258
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other