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

Catalog Number 5C5479

Device Problem Failure to Disconnect (2541)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a connection issue between the patient line of the amia cassette and the female connector of minicap transfer set.This occurred during use of the devices for peritoneal dialysis therapy.The connection issue was further described as "they were unable to disconnect the cycler patient line from the transfer set.".The nurse had the patient leave all of the cycler tubing connected to their transfer set but clamped and come into the clinic.When patient arrived, rn changed out the transfer set per protocol, leaving it connected to the tubing.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation with the white adapter attached to the female connector of the transfer set.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The white adapter was hand removed from the female connector.There were no leaks or issues observed.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
• MDR Report Key: 12394397
• MDR Text Key: 269015715
• Report Number: 1416980-2021-05339
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412153186
• UDI-Public: (01)00085412153186
• Combination Product (y/n): Y
• PMA/PMN Number: K151525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

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 Expiration Date: 12/14/2023
• Device Catalogue Number: 5C5479
• Device Lot Number: H21F14045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MINICAP TRANSFER SET; MINICAP TRANSFER SET