MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M100 SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 106697

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

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 01/03/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that after continuous veno-venous hemofiltration (cvvh), using a prismaflex m100 set, an intensive care unit patient experienced a cardiac arrest and subsequently passed away.It was reported two minutes after starting therapy the patient became restless and asked for therapy to be discontinued.Fifteen minutes after starting therapy an extreme negative pressure alarm was generated.Fifteen minutes later therapy was discontinued.Eighteen minutes after therapy was discontinued, the patient was unresponsive and three minutes after the patient experienced cardiac arrest and passed away.During treatment, citrate was provided and there were no coagulation issues.There was no report of a medical intervention associated with this event.The cause of death was reported as due to cardiac arrest.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

Additional information: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.The patient¿s comorbidities of critical condition with septic shock, acute cardiac failure and paroxysmal atrial fibrillation, have been assessed as contributing factors to the patient¿s death.Upon further investigation, no malfunction was reported on the prismaflex m100; therefore, the prismaflex m100 is no longer considered suspect in this event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX M100 SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu cedex rhone
• Manufacturer (Section G): BAXTER HEALTHCARE - MEYZIEU; 7, av lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8471235
• MDR Text Key: 140545435
• Report Number: 8010182-2019-00090
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/01/2019,05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 106697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2019
• Distributor Facility Aware Date: 03/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2019
• Date Manufacturer Received: 05/02/2019
• 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: N
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX CONTROL UNIT
• Patient Outcome(s): Death
• Patient Age: 66 YR