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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number L5C4531
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Date of event: the event occurred on an unspecified date in december 2022 mfr site: the device was manufactured at one of the following facilities: baxter healthcare - (b)(6).Baxter healthcare - (b)(6).The device was discarded, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that there was a pinhole in the patient line of an unspecified quantity of homechoice automated pd sets with cassette which resulted in a leak.This occurred during use of the device for peritoneal dialysis (pd) therapy.There was no report of 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 CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
see h10
see h10
see h10
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key16278082
MDR Text Key308651181
Report Number1416980-2023-00241
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102936
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/01/2023
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 NumberL5C4531
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/11/2023
Initial Date FDA Received02/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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