MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A.S. MEDEX LOGICAL PRESSURE MONITORING SYSTEM; DRS-TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number MX9604CZ

Device Problem Leak/Splash (1354)

Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 04/20/2015

Event Type  Injury  

Event Description

User facility reported that the device was in use with patient (time in use not provided).According to reporter, leakage occurred at the trigger flush portion of the set.According to reporter, the patient had blood loss and drop in blood pressure as a result.The monitoring device was exchanged for another; no permanent effects to patient occurred.

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

• Brand Name: MEDEX LOGICAL PRESSURE MONITORING SYSTEM
• Type of Device: DRS-TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A.S.; hranice ; EZ
• Manufacturer (Section G): SMITHS MEDICAL CZECH REPUBLIC A.S.; olomoucka 306; hranice 1 - mesto; hranice 753 01; EZ 753 01
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4795871
• MDR Text Key: 5856372
• Report Number: 2183502-2015-00363
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MX9604CZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2015
• Distributor Facility Aware Date: 04/20/2015
• Event Location: Hospital
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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