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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE PRISMAFLEX M150 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE PRISMAFLEX M150 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 109990
Device Problem Air/Gas in Device (4062)
Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/06/2021
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that, following fifteen minutes of continuous renal replacement therapy (crrt) using a prismax machine and a prismaflex m150 set, the patient's blood pressure decreased from 100/50 to 40/20 mmhg. Medical intervention, including titrating up vasopressors, was provided. An ¿air in blood¿ alarm was then generated and large amount of air was reportedly seen at the top of the m150 filter along with foam. The treatment was terminated without returning the extracorporeal (ec) blood to the patient. A blood loss of 217 ml was reported. An unspecified bolus of fluid replacement was provided together with albumin and, following decrease of hemoglobin from 8. 8 to 7. 2 g/dl, a blood transfusion was prescribed. No additional information is available.
 
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Brand NamePRISMAFLEX M150
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE
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 
2242702068
MDR Report Key12259173
MDR Text Key264500831
Report Number8010182-2021-00229
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K080519
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number109990
Device Lot Number20I0504
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2021
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 Initial

Patient Treatment Data
Date Received: 08/02/2021 Patient Sequence Number: 1
Treatment
AUTO EFFLUENT SET; NORMAL SALINE; PRISMAX V2 US; THERMAX; THERMAX POUCH
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