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U.S. Department of Health and Human Services

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

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GAMBRO AB PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 7.20
Device Problem Device Alarm System (1012)
Patient Problems Sepsis (2067); Injury (2348); Respiratory Failure (2484)
Event Date 02/01/2020
Event Type  malfunction  
Event Description
Patient on crrt, circuit overdue for change by 1 day (last changed tuesday (b)(6), it is two days later. Alarm for "self test failed" went off, giving rn two choices: retest or disconnect. Attempted to retest 3 times, but circuit quickly alarmed for same reason. When option to disconnect was chosen, there was no option to return blood. This is a critically ill pt with pre b cell all, status post sacrococcygeal teratoma (sct) in the icu for sepsis, veno-occlusive disease (vod), acute kidney injury (aki), and respiratory failure. She is on norepinephrine for blood pressure support, and receives multiple blood products each shift. Her latest hct
=
29. Circuit had not had any such alarms this shift, nor were any passed on during report. We had planned a circuit change this afternoon already, so circuit stopped itself at a convenient time. However, unable to return blood - pt lost 187ml blood due to this. I-stat gas shows hct 24. No changes in patient status, still on norepinephrine, no increase in oxygen requirement or physical symptoms. Troubleshoot equipment. Could this have been avoided had circuit been changed on time, or would it not have made a difference?.
 
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Brand NamePRISMAFLEX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO AB
one baxter parkway
deerfield IL 60015
MDR Report Key9847294
MDR Text Key183902879
Report Number9847294
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2020
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number7.20
Device Catalogue Number955542
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/12/2020
Event Location Hospital
Date Report to Manufacturer03/18/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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