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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
Catalog Number ASKU
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2023
Event Type  malfunction  
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, 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 patient line which resulted in leak, which is known to cause this alarm.The cause of the leak could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a homechoice device alarmed system error 2240 (air in line/set).The patient was connected at the time of the alarm.This occurred during drain two of five of peritoneal dialysis (pd) therapy.During the troubleshooting, it was reported that there was a hole in the patient line which resulted in a leak that led to this alarm.Renal therapy services (rts) assisted the patient with clearing the alarm and advised to contact their nurse regarding the issue.Proper procedures per the user manual were reviewed with the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
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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 Key16709882
MDR Text Key313012699
Report Number1416980-2023-01666
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 04/10/2023
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 NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/16/2023
Initial Date FDA Received04/10/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
HOMECHOICE DEVICE; UNSPECIFIED PD SOLUTION
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