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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 Material Puncture/Hole (1504); Protective Measures Problem (3015)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/11/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a homechoice device experienced a system error 2240 (air in line/set) alarm.The patient was connected at the time of the alarm.This occurred during drain one of five of peritoneal dialysis (pd) therapy.During the troubleshooting, it was reported that there was a hole in the patient line of the homechoice cassette that led to this alarm.No sharp objects were used to open the cassette packaging and no pets in the room when performing dialysis.Renal therapy services (rts) reviewed proper procedures per the user manual with the patient.The patient would start over with new supplies.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
H10: 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
MDR Report Key9673622
MDR Text Key178035296
Report Number1416980-2020-00436
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00085412090078
UDI-Public(01)00085412090078
Combination Product (y/n)N
PMA/PMN Number
K102936
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 03/05/2020
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 NumberH19J18035
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/11/2020
Initial Date FDA Received02/05/2020
Supplement Dates Manufacturer Received03/02/2020
Supplement Dates FDA Received03/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
HOMECHOICE
Patient Age63 YR
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