• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE CORPORATION; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number ASKU
Device Problems Material Puncture/Hole (1504); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2024
Event Type  malfunction  
Event Description
It was reported that a homechoice device experienced a system error 2267 (air in line/set) alarm.The patient was connected at the time of the alarm.This occurred during dwell one of four of peritoneal dialysis therapy.During troubleshooting, it was reported that there was a hole in the supply line of the homechoice cassette that led to this alarm.Renal therapy services (rts) assisted the patient with clearing the alarm and advised the patient to start over with all new supplies and contact their nurse regarding the issue.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
G1 manufacturing facility - this device was manufactured at one of the two following manufacturing sites: baxter healthcare - mountain home.1900 n highway 201, mountain home, ar 72653, united states.Baxter healthcare - dominican republic.Carretera sanchez km 18.5, parque industrial itabo, piisa haina san cristobal 91000, dominican republic.An alarm indicative of a potential malfunction of the disposable cassette was reported.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.However, a hole in the supply line of the homechoice cassette was reported, which is known to cause this alarm.The cause of the hole in the supply line of the homechoice cassette could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NI
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 Key18894388
MDR Text Key337549168
Report Number1416980-2024-01093
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
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 03/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received02/19/2024
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
HOMECHOICE DEVICE.; UNSPECIFIED PD SOLUTION.
-
-