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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF1000 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF1000 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 107140
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/23/2021
Event Type  malfunction  
Manufacturer Narrative
Address: (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during therapy with two units of prismaflex hf1000 set, air bubbles were observed to be drawn into the extracorporeal (ec) circuit through the ¿free replacement solution tubing after the pod/wheel; fluid present between free bag and pod¿. Air entered the hf1000 filter and treatment was terminated without returning the ec blood to the patient. Air appeared to be coming from a possible damage to the tubing at the pod. A new filter was used and the same issue began almost immediately upon initiation. Blood was not returned to the patient. There was patient involvement but no injury and medical intervention was reported. No additional information is available.
 
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Brand NamePRISMAFLEX HF1000
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - MEYZIEU
7, av lionel terray, b.p. 126
meyzieu cedex rhone 69883
FR 69883
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12028584
MDR Text Key259591275
Report Number8010182-2021-00199
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K042938
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2022
Device Catalogue Number107140
Device Lot Number20C0503
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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