MAUDE Adverse Event Report: ATRION COMPANY QUEST MEDICAL INC; MPS2 CARDIOPLEGIA DELIVERY SYSTEM

Model Number MPS2

Device Problems Display or Visual Feedback Problem (1184); Insufficient Flow or Under Infusion (2182)

Patient Problem Underdose (2542)

Event Date 08/22/2013

Event Type  malfunction  

Event Description

During the initial phase of cardiopulmonary bypass support, with the aortic cross-clamp occluding the aorta, several attempts were made to achieve cardiac arrest using the mps2 cardioplegia system, all of which proved unsuccessful.Due to apparent inconsistencies in cardioplegia delivery, special attention was given to accessing the mechanical parameters of the mps2 and it seemed fully operational yet when quantifying the amount of cardioplegia solution being delivered there were measurable volume incongruities.The numeric total reported from the pump module and that being measured at the site of infusion (measured in a graduated cylinder) demonstrated discrepancies as large as 100 mls less than measured from the mps2 system.In addition, infusion pressures (measured at the pump console) exceeded "normal" parameters and due to their high values, interfered with an ability to provide adequate perfusion flows during injection of cardioplegia.Due to these combined malfunctions a decision was reached to remove the disposable components and exchange it with another.Once the replacement software was primed and prepared for cardioplegia delivery, cardiac arrest was achieved and the remainder of the procedure was uneventful.Though conjecture on my part, the inability to adequately deliver cardioplegia in arresting the heart at the beginning of the procedure did not have a "direct" adverse effect on the pt but equipment malfunction, assessment and replacement of the software delayed the course of action and prolonged surgery by an estimated 30 minutes.Once the equipment issue was resolved, the procedure proceeded as expected and the net outcome provided a successful repair without any detrimental effects to the pt.The cardioplegia system was returned to the mfr on (b)(4) 2013 for eval.Testing was performed on (b)(4) 2013 in an attempt to replicate events of inadequate cardioplegia flow and "the root cause of the alleged defect is unk"; according to quest medical, inc.

• Brand Name: QUEST MEDICAL INC
• Type of Device: MPS2 CARDIOPLEGIA DELIVERY SYSTEM
• Manufacturer (Section D): ATRION COMPANY; allen TX
• MDR Report Key: 3596862
• MDR Text Key: 21052453
• Report Number: MW5033984
• Device Sequence Number: 1
• Product Code: DTR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MPS2
• Device Catalogue Number: 5001102
• Device Lot Number: 0444983E02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2013
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 82