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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX M60 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX M60 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 106696
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Blood Loss (2597); Bronchospasm (2598)
Event Date 01/13/2021
Event Type  Injury  
Manufacturer Narrative
Facility name: (b)(6) hospital, should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a pediatric patient became hypotensive and experienced tachycardia approximately two hours after starting continuous renal replacement therapy using a prismaflex control unit and a prismaflex m60 filter. The patient was treated with a fluid bolus and one dose of calcium. The patient's condition was reported to have stabilized. On the same day, reported as later in the evening, a check return alarm, immediately followed by a return disconnection alarm and then immediately followed by an air in blood alarm was generated by the prismaflex control unit. No disconnection or air in the return line was observed. The air in blood alarm could not be cleared and the nurse was unable to hit stop during the air in blood alarm. The machine was turned off and the blood was not returned. The amount of blood loss was not reported. The patient was re-connected to a new prismaflex control unit and a new prismaflex m60. Thirty minutes later, the patient experienced bronchospasm, hypotension and tachycardia in the 160s. The pre blood pump prescription was increased and the patient was given a fluid bolus and two doses of calcium. The patient's condition stabilized. Shortly afterwards, "the patient was at full flows on the circuit per prescription" and the patient began to show clinical signs of change. Approximately twenty minutes later, the machine alarmed with return disconnection and filter clotting. At this time, the patient started seizing, experienced bradycardia, and became hypotensive. At this time, the patient's pupils were observed to be fixed and no pulse was palpable. Treatment was terminated and blood was not returned to the patient. Amount of blood loss was not reported. Cardiopulmonary resuscitation was performed for 45 minutes before the patient stabilized and was placed on extracorporeal membrane oxygenation. No additional information is available.
 
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Brand NamePRISMAFLEX M60
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
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 Key11290579
MDR Text Key234393007
Report Number8010182-2021-00035
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number106696
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2021
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 Unkown

Patient Treatment Data
Date Received: 02/07/2021 Patient Sequence Number: 1
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