MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR

Catalog Number MX4710

Device Problem Leak/Splash (1354)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.Investigation in process.

Event Description

The user facility reported that the listed device was in use with a cardiac patient when the patient developed hypotension.According to the reporter, the patient's arterial line clotted during the event.The patient was treated for hypotension, and patient's arterial line was replaced.According to the reporter, the patient's conditions were caused by a leak in the pressure cuff that was not immediately noted by the health care personnel.The patient's arterial line and pressure cuff were replaced.Additional information regarding patient identifiers, patient's symptoms and provided treatment has been requested; no information has been made available at this time.No permanent injury was reported.

Manufacturer Narrative

A total of thirteen devices were received for evaluation.None of the samples were the actual device involved in the reported event.All samples were given leakage testing.Two of the samples did not pass leakage testing.Inspection of the pressure gauges of these two devices found a tear in the gauge's diaphragm, therefore a scar (supplier corrective action request) was sent to the supplier.The remaining 11 samples passed leakage testing.However, evaluation of similar devices found that there may still be a slow leak in the weld seal between the pressure gauge cap and housing.A capa has been to opened for further investigation and implementation of corrective actions.

• Brand Name: MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR
• Type of Device: PRESSURE INFUSOR
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings rd.; dublin OH 43016
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5566231
• MDR Text Key: 42379419
• Report Number: 2183502-2016-00765
• Device Sequence Number: 1
• Product Code: KZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MX4710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 04/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention