MAUDE Adverse Event Report: CVVH MACHINE

Device Problems Kinked (1339); Failure to Pump (1502); Device Operates Differently Than Expected (2913)

Patient Problems Low Blood Pressure/ Hypotension (1914); Thrombus (2101)

Event Date 03/28/2015

Event Type  Injury  

Event Description

Two separate life threatening product difficulties during liver transplant procedure.Cvvh unit malfunctioned, thought to be due to improperly crimped/impeded tubing; resulted in clotted central venous line, requiring intra-operative replacement under the drapes in difficult and less-than-perfectly-sterile conditions; patient was at that time found to have a right atrial thrombus or mass, mobile, on transesophageal echo; this may be related to the cvvh difficulties (impossible to ascertain).Extreme "distration" of the dozens of error events from the cvvh machine made the care of the patient difficult.There were two near-fatal hypotensive episodes that may potentially be the result of this machine's failures.Belmont fluid management system device serial (b)(4) failed to pump on three occasions, which resulted in life-threatening delays in effective therapy for the hypotensive episodes.In each instance, the fms device alarmed that its fluid cannister was empty, when in fact the bowl properly held hundreds of ml of fluid and the lines appeared straight and unkinked.A replacement fms machine was emergently obtained and functioned without difficulty for the remainder of the liver transplant procedure.These devices (cvvh machine, and belmont fms pump) were in use during a 9-hour liver transplant performed at (b)(6).The risk management department has been notified.

• Brand Name: CVVH MACHINE
• Type of Device: CVVH MACHINE
• MDR Report Key: 4665000
• MDR Text Key: 5731922
• Report Number: MW5041917
• Device Sequence Number: 1
• Product Code: KDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 80