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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE CORPORATION; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Lot Number ASKU
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
The device was an unknown prismaflex set facility name: (b)(6) hospital ((b)(6)).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the filter of one (1) unit of a prismaflex set was observed to be broken resulting in a leak.The event occurred during patient treatment.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
NI
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key12407898
MDR Text Key272523097
Report Number8010182-2021-00258
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/02/2021
Initial Date FDA Received09/01/2021
Supplement Dates Manufacturer Received10/26/2021
Supplement Dates FDA Received10/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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