MAUDE Adverse Event Report: BENCHMARK ELECTRONICS INC. AMIA AUTOMATED PD SYSTEM; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 5C9320

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the amia cycler delivered 300 ml more solution than prescribed.This occurred during fill of peritoneal dialysis therapy and the patient was connected at the time of the event.The technical services representative initiated a swap of the device and discussed the use of continuous ambulatory peritoneal dialysis with the patient until the new machine arrives.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received by baxter, and an evaluation is complete.A device history review revealed no issues that could have caused or contributed to the reported issue.Internal and external inspection was performed and no issues were noted.The reported issue of overdelivery was not verified in the device log.Logs revealed the patient received the prescribed volume for the last 3 therapies performed.The pneumatic system was checked using the service interface t3 tab and passed.A short simulated therapy was performed and completed successfully.The reported condition was not verified.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): BENCHMARK ELECTRONICS INC.; winona MN
• Manufacturer (Section G): BENCHMARK ELECTRONICS INC.; 4155 theurer blvd; winona MN 55987
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6332840
• MDR Text Key: 67505167
• Report Number: 1416980-2017-01305
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C9320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 39 YR