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

Catalog Number 5C5479

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Event date was sometime in (b)(6) 2018.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a hole was found in an amia cassette.The location was not reported.The reporter stated that the device displayed ¿cassette failure¿ when using the cassette.The reporter stated that they completed therapy by using cassette with a different lot number.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, a companion sample was received for evaluation.A visual inspection was performed with naked eye with no issues noted.Functional testing including leak testing, clear passage testing and clamp function testing were performed with no issues noted.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported problem was not verified.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 - MOUNTAIN HOME; mountain home AR
• 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: 7668517
• MDR Text Key: 113397214
• Report Number: 1416980-2018-04162
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2020
• Device Catalogue Number: 5C5479
• Device Lot Number: H18A28082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1