MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M100; 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 Air Embolism (1697); Death (1802); Dyspnea (1816); Loss of consciousness (2418); Respiratory Failure (2484); Lethargy (2560); Blood Loss (2597)

Event Date 07/07/2019

Event Type  Death  

Manufacturer Narrative

A medwatch was submitted by the customer to the fda under id: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient passed away during continuous renal replacement therapy (crrt) after experiencing air embolism, a change in mental status, blood loss, respiratory failure, lethargy, unresponsiveness and guppy breathing.The patient was connected to a prismaflex control unit and a prismaflex m100 set during the event.It was reported that the patient was transferred from a different hospital due to shortness of breath, recurrent pleural effusions, edema.It was reported the patient developed respiratory failure and was intubated.Crrt was also initiated.A tracheostomy was placed a few weeks later.Four days after tracheostomy, a tunneled hemodialysis catheter was placed and exchange of right neck central venous catheter was performed.The patient was alert and communicative during entire admission.Twenty-five days after patient transfer (in the morning), the mental status of the patient was noted to have changed.The bedside nurse noted air bubbles coming out of both the hemodialysis catheter and the central venous catheter.The filter was changed and a new filter was used to continue therapy.The extracorporeal blood was not returned to the patient.Approximately two hours later, air was again noted in the filter.The connection of the bags and pins were inspected and all connections appeared to be secured.The air was observed to be coming from the patient access line.The hemodialysis line was flushed and drew back without any resistance, however, a "ton of small air bubbles " was noted in the syringe (1-2 ml).The caps (not further specified) were changed and there was still pulling back of air bubbles.The bedside nurse connected directly to the catheter without a cap, and the same thing was noted.Air bubbles were also noted when drawing back from the patient's triple lumen central line.Subsequently, the patient became increasingly lethargic and less responsive, and was guppy breathing on the ventilator.The patient was removed from life sustaining measures and the patient passed away.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation, as the customer decided that a third-party investigator will be evaluating the involved prismaflex m100 set.Until now, no investigation results were received.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction: removal of information in section f related to importer.The initial report inadvertently, included the importer report number.This mdr should have been submitted only with the mfr.Number (and not as importer).

• Brand Name: PRISMAFLEX M100
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu cedex rhone
• MDR Report Key: 8972609
• MDR Text Key: 156867271
• Report Number: 8010182-2019-00178
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414064556
• UDI-Public: (01)07332414064556
• Combination Product (y/n): N
• PMA/PMN Number: K041005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2019,12/18/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: 106697
• Device Lot Number: 18K2101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2019
• Distributor Facility Aware Date: 08/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2019
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 09/27/2019; 12/17/2020
• Supplement Dates FDA Received: 10/21/2019; 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CATHETER LONG TERM; PRISMAFLEX MACHINE
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 49 YR