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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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BAXTER HEALTHCARE CORPORATION; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Device Problems Device Difficult to Setup or Prepare (1487); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device was not returned and the lot number was unknown; therefore, a device analysis could not be completed.If additional relevant information is obtained, then a follow-up mdr will be submitted.
 
Event Description
This is a report of a patient who had difficulty connecting a supply bag to an unknown cassette.This occurred during an unspecified step of peritoneal dialysis therapy.There was no report of patient injury, medical intervention, or adverse event associated with this event.No additional information is available at this time.
 
Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
 
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Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
Manufacturer Contact
christina arnt
25212 w. illinois route 120
round lake, IL 60073
2242703198
MDR Report Key3995238
MDR Text Key15549467
Report Number1416980-2014-25850
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/09/2014
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 Unknown
Patient Sequence Number1
Treatment
HOMECHOICE, PHYSIONEAL 40 2.27%
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