MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET

Model Number T005025M

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 08/19/2014

Event Type  malfunction  

Manufacturer Narrative

The device history record review was completed and all manufacturing inspections passed with no non-conformances.No further actions will be taken at this time.

Manufacturer Narrative

The pressure monitoring product that is related to this complaint was custom designed specifically for one hospital that is located outside of the united states.This product is not similar to any product that is used on patients inside of the united states.This hospital returned all unused product inventory to edwards lifesciences.An investigation ensued after notification of this event.A sr.Director of engineering and a sr.Manager of product safety from edwards visited the hospital located in the netherlands to receive firsthand knowledge of the event.The concerns expressed by the customer were: (1) the manifold becomes loose from the dpt side when manipulated, (2) the manifold becomes loose from the patient side when manipulated, and (3) the connection to the pressure tubing at the dpt becomes loose when manipulated.To examine these concerns, 20 models from the finished goods inventory were examined.Loose connections were detected in 1 out of 20 units at the patient side connector to the manifold.None of the other connections on these units were loose.The unit with the loose connection initially failed the leak testing, but after proper attachment of the connection, the unit passed the leak test.Additional investigation of the units found that 3 out of 20 manifolds had increased friction of the ¿rotating nut¿ on the patient side connection when the nut was pulled forward.This information was shared with the supplier of the manifold.All components were inspected and all components met specifications per their applicable drawings.In addition, 100 units in the next production lot were inspected for the measurements of the gap between the male luer connector on the pressure tubing and the rotating nut on the manifold.The results showed that there was a significant amount of variation in the tightening of that connection in this model.Based on the discussions and investigation results, it can be confirmed that the components met all specifications.

Event Description

It was reported that the pressure monitoring set with manifold was used to monitor the cvp measurements and administer medication through the dpt system.The patient was administered noradrenaline and milrinone through the dpt system.The system was changed out after 72 hours.One hour later, the patient started having blood pressure fluctuations from 45-250mmhg systolic.The dosage of the medication was changed, but there was no improvement of the hemodynamic status.The clinician checked the dpt system and discovered the manifold was disconnected on the sensor side of the manifold.Estimated time of detachment was 1 minute.The patient was stabilized.No blood loss was reported.

Manufacturer Narrative

The product was discarded by the hospital and was not returned for evaluation.The complaint could not be confirmed without a product return, nor could potential contributing factors be identified.No further actions will be taken at this time.

• Brand Name: PRESSURE MONITORING SET
• Type of Device: PRESSURE MONITORING SET
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina, san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4061367
• MDR Text Key: 12171257
• Report Number: 2015691-2014-02055
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: T005025M
• Device Lot Number: 59676098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2014
• Initial Date FDA Received: 09/04/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/29/2014; 10/17/2014
• 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: Initial
• Patient Sequence Number: 1
• Treatment: NORADRENALINE AND MILRINONE
• Patient Outcome(s): Other