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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX MONITOR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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GAMBRO INDUSTRIES PRISMAFLEX MONITOR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 03/14/2018
Event Type  Injury  
Event Description
Prisma alarmed with a communication error requiring that set be removed from patient and did not allow rn to return any blood to patient. Shortly after the set was removed from the patient, the blood pressure quickly started dropping into 50's requiring an increase in pressors, arterial blood gas, and added labs.
 
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Brand NamePRISMAFLEX MONITOR
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO INDUSTRIES
32650 n. wilson rd.
round lake IL 60073
MDR Report Key7384695
MDR Text Key103938785
Report Number7384695
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/27/2018,03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/27/2018
Event Location Hospital
Date Report to Manufacturer03/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/30/2018 Patient Sequence Number: 1
Treatment
NOT KNOWN.
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