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); Protective Measures Problem (3015)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

An alarm indicative of a potential malfunction of the disposable cassette was reported.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.However, a hole was reported in an unspecified line of the amia cassette, which is known to cause this alarm.The cause of the hole could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an amia device experienced an unspecified alarm; further described as "error in line".It was further reported that "the patient suspected a hole or air in line, however uncertain".The patient was connected at the time of the alarm.This occurred during an unspecified process step of peritoneal dialysis therapy.The patient disconnected and ended the therapy session.There was no report of patient injury, however, the patient was given a prophylactic antibiotic (one-time dose of intraperitoneal ancef, one gram) as precautionary measure.Additionally, the patient¿s transfer set was changed as a precautionary measure.No additional information is available.

• 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: 18946360
• MDR Text Key: 338220070
• Report Number: 1416980-2024-01247
• Device Sequence Number: 1
• Product Code: FKX
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5C5479
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• 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