MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. LOGICAL DOUBLE PRESSURE MONITORING KIT; IBP - BLOOD PRESSURE MONITORING SET

Catalog Number DPS721429

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2014

Event Type  malfunction  

Event Description

The user facility reported that the device was in use with a patient for pressure monitoring while infusing heparinized saline.During a routine check, it was noted that the arterial line was backflowing and the saline bag was empty.The user facility replaced the bag of heparinized saline and observed the solution to be infusing quickly and the patient's blood pressure reading was higher than nibp.Visual inspection by the user facility found that the flush valve appeared to be stuck slightly open and the saline solution was therefore infusion at a higher rate than expected.No adverse effects to the patient were reported.

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.(b)(4).

• Brand Name: LOGICAL DOUBLE PRESSURE MONITORING KIT
• Type of Device: IBP - BLOOD PRESSURE MONITORING SET
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; rossendale ; UK
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3976127
• MDR Text Key: 4754927
• Report Number: 2183502-2014-00389
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DPS721429
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2014
• Distributor Facility Aware Date: 05/11/2014
• Event Location: Hospital
• Date Manufacturer Received: 05/11/2014
• Was Device Evaluated by Manufacturer?: No
• 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