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

Catalog Number 5C5479

Device Problem Air/Gas in Device (4062)

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

Event Date 03/29/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a patient experienced air in the patient line of an amia cassette.This occurred during use of the device for peritoneal dialysis therapy.The patient was connected at the time of the event.Renal therapy services (rts) advised the patient to end therapy.The patient completed therapy manually.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction b5: the reported condition caused the machine to alarm ¿air in patient line¿.This occurred during an unspecified process step of peritoneal dialysis therapy.There was nothing unusual found during troubleshooting that would cause or contribute to the alarm (omitted on the initial report).Additional information 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 discarded; therefore, a device analysis could not be completed.Low priority alarm 30166 was retrieved from the share source log review and could be an attribute to the reported alarm.Therefore, the reported condition was verified.However, without a sample to evaluate, the root cause for the alarm is unknown.This alarm was not associated with a reported death or serious injury, or a malfunction that could result in a death or serious injury.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: 16790049
• MDR Text Key: 313821155
• Report Number: 1416980-2023-01922
• 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: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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: H22I07042
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2023
• Date Device Manufactured: 09/07/2022
• 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