MAUDE Adverse Event Report: BAXTER HEALTHCARE - ROUND LAKE AMIA AUTOMATED PD SYSTEM; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 5C9320

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Malaise (2359); Chest Tightness/Pressure (2463); Abdominal Distention (2601)

Event Date 08/18/2019

Event Type  Injury  

Manufacturer Narrative

The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported after an automated peritoneal dialysis patient woke up feeling bad, experienced wheezing, chest tightness, difficulty breathing and a feeling of being overfilled.The patient was connected to the amia device at the time of the events.It was reported the device did not generated an alarm.It was reported the patient called the nurse and was instructed to drain.It was reported the patient lost ¿8 pounds¿ after the drain and felt relieved of the symptoms.Renal therapy services (rts) initiated a swap of the device.There was no report of medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: the device was received for evaluation.A short-simulated therapy was performed and was completed successfully without any delay or alarms.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported issue was not verified.The cause of the condition could not be determined.No device failure or malfunction was identified that could have caused or contributed to the reported event; therefore, the amia device is no longer considered suspect product in this event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AMIA AUTOMATED PD SYSTEM
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - ROUND LAKE; round lake IL
• Manufacturer (Section G): BAXTER HEALTHCARE - ROUND LAKE; 25212 w. illinois route 120; round lake IL 60073
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8982655
• MDR Text Key: 157135254
• Report Number: 1416980-2019-04960
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C9320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other