MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. AMIA AUTOMATED PD CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C9320
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an amia automated pd system underdelivered peritoneal dialysis (pd) solution to the patient.This issue was further described as, ¿machine seems not to be taking the correct amount of solution, there was much more fluid remaining at the end of therapy¿.This occurred during an unspecified process step of peritoneal dialysis therapy.Continuous ambulatory peritoneal dialysis was discussed.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Correction h5 and h8.H5: label for single use? replace yes with no.H8: usage of device: remove initial use of device and replace with reuse.H11: the device was received for evaluation.An external visual inspection revealed the device to be in good condition.A functional pneumatic integrity test was performed and all hydraulic valves actuated when prompted.Internal connections were correct and secure.A pump control session was performed and the fill and deliver volumes were exactly the same value.The reported condition was not verified.The device met specifications.A service history evaluation was performed, and no issues were found during prior servicing related to the reported problem.As peritoneal dialysis (pd) therapy is often prescribed as a chronic therapy, it is unlikely that an isolated event which transiently decreases pd therapy will result in a clinically detectable or significant harm.If necessary, the patient can continue pd therapy using manual supplies.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AMIA AUTOMATED PD CYCLER
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BENCHMARK ELECTRONICS INC.; 4065 theurer blvd; winona MN
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20439725
• Report Number: 1416980-2024-05712
• Device Sequence Number: 8166112
• Product Code: FKX
• UDI-Device Identifier: 00085412490120
• UDI-Public: 00085412490120
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K151525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 5C9320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED PD SOLUTION
• Patient Sex: Unknown