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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 Inoperable (1663); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2013
Event Type  malfunction  
Event Description
During evaluation of a returned homechoice device, a system error 2240 alarm (air in set) was identified in the log which indicates a potential malfunction of the disposable cassette.The alarm occurred on (b)(6) 2013 at 14:11:56.No additional information is available.
 
Manufacturer Narrative
(b)(4).During evaluation of a homechoice hardware device an alarm indicative of a potential malfunction of the disposable cassette was identified.As the cassette was not returned and the lot number is unknown, a device analysis cannot be completed.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 Key3790515
MDR Text Key4445734
Report Number1416980-2014-14480
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeBR
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
Report Date 04/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2014
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
Date Manufacturer Received04/10/2014
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
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