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

Catalog Number 5C5479

Device Problems Fluid/Blood Leak (1250); Occlusion Within Device (1423); Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that an amia automated pd set with cassette had a borla clamp that was slightly misaligned while clamped, resulting in incomplete occlusion of the solution line and leakage from the solution line.This was noticed during testing by the reporting facility and prior to patient use.There was no patient involvement.No additional information is available.This is report 2 of 2.

Manufacturer Narrative

(b)(4).The device is reported to be available for evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was returned to baxter and an evaluation was performed to investigate the reported problem of leak.A review of all batch record documents was performed for lot number h13k13030 with no issues noted during the manufacturing process.However, a deviation from standard procedure was noted.A new testing method for a protocol was performed on units of this lot.The lot then met the release criteria.A visual inspection was performed with no abnormalities noted.Leak testing, clamp function testing, and clear passage testing were performed with no issues noted.Upon conclusion of the evaluation, the returned sample was determined to meet visual and functional product specifications.The cause of the reported problem could not be determined.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; 1900 n highway 201; mountain home AR 72653
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3918238
• MDR Text Key: 4514143
• Report Number: 1416980-2014-21780
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: 5C5479
• Device Lot Number: H13K13030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1