MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 102297

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Loss of consciousness (2418)

Event Date 04/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that three hours into treatment with a phoenix monitor, an internal water leak was observed ¿behind the machine¿.It was reported that no alarms were generated.Treatment was discontinued, then restarted with another monitor.It was reported 1.2kg of excess fluid was removed within the three hours.The patient experienced a low heartbeat and dizziness.The patient was treated with extra saline injection (950ml), glucose (60cc) and oxygen.It was reported the patient had no symptoms after treatment ended.No additional information is available.

Manufacturer Narrative

It was reported the patient recovered after approximately 20 minutes and the treatment was completed using a different monitor.The device was evaluated on site.Visual inspection found the silicone connector near the pi (pressure inlet) pressure transducer was disconnected.The reported condition of external leak was verified.The silicone t connector was replaced.A rinse test was performed.The pump acid and ultrafiltration pump were auto calibrated.Functional test with the venous, arterial pressure, blood pump, patient sensor, pressure transducer, conductivity, temperature, bld (blood leak detector), flowmeter, air detector and pc degassing pump were performed without issue.A simulated treatment was also performed for 30 minutes, with no issues.A chemical disinfection with leak check were performed with no issues noted.The treatment time was reportedly set to 4 hours with a total ultrafiltration volume (ufv) of 2.1l.However, the hourly uf rate was set as 0.42l indicating a set treatment time of 5 hours.The cause of the condition could not be determined.A device history review revealed no issues that could have caused or contributed to the reported issue.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PHOENIX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS; medolla modena
• MDR Report Key: 8587957
• MDR Text Key: 144395874
• Report Number: 9616240-2019-00004
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K103832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 102297
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/12/2019
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 67