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U.S. Department of Health and Human Services

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

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GAMBRO LUNDIA AB PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 107493 (SW7.11)
Device Problem Use of Device Problem (1670)
Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
Event Date 06/01/2017
Event Type  Injury  
Manufacturer Narrative
N/a.
 
Event Description
A patient was undergoing continuous renal replacement therapy (crrt) on a prismaflex control unit. According to received information, the involved prismaflex crrt set (type unknown) was unloaded by the nurse during ongoing treatment without having clamped the access and return blood lines or the patient's central catheter. As a consequence, an unknown volume of blood drained into the fluid bags. The use error was immediately identified and the medical staff succeeded in stabilizing the patient's blood pressure. No additional information is available.
 
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Brand NamePRISMAFLEX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO LUNDIA AB
box 10101
lund SE-22 010
SW SE-22010
Manufacturer (Section G)
GAMBRO LUNDIA AB
box 10101
lund
SW
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6678314
MDR Text Key78764236
Report Number9616026-2017-00006
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K131516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number107493 (SW7.11)
Device Catalogue Number107493
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/29/2017 Patient Sequence Number: 1
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