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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 Peritonitis (2252)
Event Date 12/22/2022
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that while connected to a homechoice automated pd set with cassette, fluid was leaking from a hole in the patient line.The reporter stated that the liquid was leaking solution leaked on the floor.The patient called the nurse and was instructed to change all supplies.The following day the patient presented to the pd clinic and began treatment with oral cefdinir and vancomycin every five days.The patient outcome was not reported.No additional information is available.
 
Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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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 - DOMINICAN REPUBLIC
carretera sanchez km 18.5
parque industrial itabo, piisa
haina, san cristobal 91000
DR   91000
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key16363782
MDR Text Key309403451
Report Number1416980-2023-00445
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00085412090078
UDI-Public(01)00085412090078
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 Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberL5C4531
Device Lot NumberH22E20126
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/19/2023
Initial Date FDA Received02/13/2023
Supplement Dates Manufacturer Received02/20/2023
Supplement Dates FDA Received03/14/2023
Date Device Manufactured05/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CYCLER
Patient Outcome(s) Required Intervention;
Patient Age74 YR
Patient SexFemale
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