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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. BAXTER PERITONEAL DIALYSIS CYCLER AMIA (CASSETTES, SOLUTION BAG AUTOMATED PD SY; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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BAXTER HEALTHCARE CORP. BAXTER PERITONEAL DIALYSIS CYCLER AMIA (CASSETTES, SOLUTION BAG AUTOMATED PD SY; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Model Number AMIA
Device Problems Filling Problem (1233); Restricted Flow rate (1248); Manufacturing, Packaging or Shipping Problem (2975); Material Deformation (2976)
Patient Problem No Code Available (3191)
Event Date 10/19/2019
Event Type  Injury  
Event Description
Repeated defects in baxter amia peritoneal dialysis cycler cassettes and solution bags.Severly crimped lines restricting liquid flow, failure to fully fill peritoneal cavity, inability to meet therapy prescription parameters.Use of product caused negative clinical outcome - reported to dialysis dr and nurses (photo evidence available).Baxter letter to (b)(6) 2019; item referenced is admission by baxter of mfg defects, technical explanation of how these occurred, but no specific discussion of mitigation actions; numerous emails to clinicians about product defects, reply emails from baxter corp., all available upon request.Photos of defective cassettes also available upon request.Notes: cassette defect rate across 3 lots of (b)(4) cassettes was 40% - 50%; all defective cassettes reported to baxter are still in my possession and available for fda inspection.Baxter letter of (b)(6) 2019.
 
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Brand Name
BAXTER PERITONEAL DIALYSIS CYCLER AMIA (CASSETTES, SOLUTION BAG AUTOMATED PD SY
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
BAXTER HEALTHCARE CORP.
MDR Report Key9295420
MDR Text Key165994613
Report NumberMW5090958
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/01/2020
Device Model NumberAMIA
Device Catalogue NumberCYCLER CASSETTES
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other; Required Intervention;
Patient Age61 YR
Patient Weight84
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