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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M100 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
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Brand NamePRISMAFLEX M100
Type of DeviceDIALYZER, 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 Key8972609
MDR Text Key156867271
Report Number8010182-2019-00178
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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
Date FDA Received09/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2020
Device Catalogue Number106697
Device Lot Number18K2101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/06/2019
Distributor Facility Aware Date08/09/2019
Event Location Hospital
Date Report to Manufacturer09/06/2019
Date Manufacturer Received12/17/2020
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

Patient Treatment Data
Date Received: 09/06/2019 Patient Sequence Number: 1
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