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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 Problem No Consequences Or Impact To Patient (2199)
Event Date 03/05/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
A patient was undergoing continuous renal replacement therapy (crrt) on a prismaflex control unit in continuous veno-venous hemodiafiltration (cvvhdf) mode. When attempting to return the extracorporeal blood to the patient, the prismaflex filter set allegedly unloaded before the operator was able start the blood return; the access line had been connected to a saline bag and the return line was still connected to the patient. The clinician stated there was no adverse event to the patient as a result of this alarm/issue, indicating that all clamps on the filter set had been clamped by the operator as instructed in the prismaflex graphical user interface and the operators¿ manual prior to the filter set becoming unloaded. The blood volume contained in the extracorporeal circuit could not be returned to the patient. 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 Key6450387
MDR Text Key71418149
Report Number9616026-2017-00004
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 03/31/2017,03/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number107493 (SW7.11)
Device Catalogue Number107493
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/31/2017
Distributor Facility Aware Date03/05/2017
Event Location Hospital
Date Report to Manufacturer03/31/2017
Date Manufacturer Received03/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2015
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: 03/31/2017 Patient Sequence Number: 1
Treatment
PRISMAFLEX M150 SET
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