MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AMIA AUTOMATED PD CYCLER SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 5C5479

Device Problems Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2023

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that two (2) amia automated pd cycler sets had "cuts" on the patient lines.This was observed during use of the devices for peritoneal dialysis therapy.One (1) sample appeared to have "two pierced lines"; air got in peritoneal cavity.The second sample had "a puncture hole in the patient line¿ observed while inspecting supplies.The patient used a new lot of sets to continue therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the actual devices were not available; however, a companion sample was received for evaluation.A visual inspection with the naked eye did not identify any abnormalities that could have contributed to the reported condition; there were no issues noted.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AMIA AUTOMATED PD CYCLER SET
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17213199
• MDR Text Key: 318031469
• Report Number: 1416980-2023-03193
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412153186
• UDI-Public: (01)00085412153186
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

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 Number: 5C5479
• Device Lot Number: H23C06053
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 07/19/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AMIA AUTOMATED PD SYSTEM