MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® EPIDURAL MINIPACKS; ANESTHESIA CONDUCTION KIT

Catalog Number 100/391/128CZ

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

Patient Problems Death (1802); Hematoma (1884); Paralysis (1997); Sepsis (2067)

Event Date 01/12/2018

Event Type  Death  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that following removal of a smiths medical portex® epidural minipack a hematoma formed.Subsequently, lower extremity paralysis occurred requiring that a laminectomy be performed under general anesthesia.It was noted that the patient was hospitalized for lung cancer in which the patient underwent a lobectomy.However, the patient expired 36 days following due to sepsis (general complication).

• Brand Name: PORTEX® EPIDURAL MINIPACKS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL CZECH REPUBLIC A. S.; olomouck[?] 306,; hranice 1; mesto, hranice 753 0 1; EZ 753 01
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 7706311
• MDR Text Key: 114573236
• Report Number: 3012307300-2018-02892
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2022
• Device Catalogue Number: 100/391/128CZ
• Device Lot Number: 3470048
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening