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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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BAXTER HEALTHCARE - SINGAPORE HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number R5C4479
Device Problems Crack (1135); Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/21/2019
Event Type  malfunction  
Manufacturer Narrative
The actual device was not available; however, three (3) photographs were provided for evaluation.A visual inspection was performed on the photos which revealed a crack at the side of the welded cassette.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that there was a leak in the homechoice cassette.The cassette was cracked and the chamber burst.This occurred while in use for automated peritoneal dialysis.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
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Brand Name
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
BAXTER HEALTHCARE - SINGAPORE
singapore
Manufacturer (Section G)
BAXTER HEALTHCARE - SINGAPORE
2 woodlands industrial park d
singapore 73875 0
SN   738750
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8520167
MDR Text Key142130379
Report Number1416980-2019-02058
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial
Report Date 04/16/2019
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 Lay User/Patient
Device Catalogue NumberR5C4479
Device Lot NumberS18I07023
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/21/2019
Initial Date FDA Received04/16/2019
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 N
Patient Sequence Number1
Treatment
HOMECHOICE
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