MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; ANESTHESIA KIT SPINAL

Catalog Number 3717C-20

Device Problem Device Inoperable (1663)

Event Date 02/05/2014

Event Type  malfunction  

Event Description

The certified registered nurse anesthetist (crna), who was performing the spinal anesthesia procedure, stated: "had a good swirl.I know i was in the space and yet there was no sensor or motor effect." subsequently, the level of anesthesia was required to be deepened.There were no complications, and the patient was transferred to the post-anesthesia care unit (pacu) in stable condition.

• Brand Name: PORTEX
• Type of Device: ANESTHESIA KIT SPINAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 1265 grey fox rd.; arden hills MN 55112
• MDR Report Key: 3636362
• MDR Text Key: 4179015
• Report Number: 3636362
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/07/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 3717C-20
• Device Lot Number: 2618245
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 82