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

Catalog Number	103453
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a patient being treated with a phoenix dialysis machine experienced a cardiac event within minutes of starting therapy.Resuscitation attempt was successful and the patient was hospitalized.The cause of the event was unknown.No further medical intervention was reported.Hospitalization was ongoing at the time of this report.No additional information is available.
Additional Manufacturer Narrative
It was reported that within 2-3 minutes after starting treatment, the patient experienced a cardiac episode, seizure like activity, unresponsiveness, pulseless, agonal breathing and the patient¿s face turned blue/purple.Treatment was discontinued.It was reported a code was called and cardiopulmonary resuscitation (cpr) was initiated.A swishing sound was heard during heart auscultation and was advised not to shock via aed device.Oxygen 8l was provided.The patient recovered consciousness and normal breathing resumed.It was reported the event started as soon as the blood had passed through the extracorporeal circuit.The extracorporeal blood was not returned to the patient.It was reported the total blood loss was 100 ml.The patient was admitted to hospital for ¿a couple of days with a cardiac workup¿.It was reported the patient received another treatment the same day after hospital admission.Pre treatment blood pressure was 210/80 mmhg and pulse 75 bpm.D11: revaclear 300 dialyzer, hd cartridge line h10: the device was not received for evaluation; therefore, a device analysis could not be completed.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.It was reported the event occurred right after starting treatment (as soon as the blood had passed through the extracorporeal circuit) and diffusion or ultrafiltration had not started; therefore, the phoenix unit is no longer considered suspect product in this event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PHOENIX
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS; medolla modena
• MDR Report Key: 8426545
• Report Number: 9616240-2019-00002
• Device Sequence Number: 2170991
• Product Code: KDI
• UDI-Device Identifier: 07332414042035
• UDI-Public: (01)07332414042035
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K103832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019
• Report Date (Section F): 03/15/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 103453
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2019
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 03/16/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BICARBONATE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Date Report Sent to FDA: 03/15/2019