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

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.

• 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 Key: 9673622
• MDR Text Key: 178035296
• Report Number: 1416980-2020-00436
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412090078
• UDI-Public: (01)00085412090078
• Combination Product (y/n): N
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• 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 Number: L5C4531
• Device Lot Number: H19J18035
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HOMECHOICE
• Patient Age: 63 YR