MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number T5C4476

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Upon completion of the investigation, or if any additional relevant information is received, a supplemental report will be submitted.

Event Description

It was reported that an effluent sample bag leaked during draining.The doctor could not identify the location of the leak.There was no patient injury or medical intervention reported.No additional information is available.

Manufacturer Narrative

(b)(4).The device was returned and an evaluation was performed.A visual inspection with naked eye and magnification with issues noted, hole in tubing port (near port seal).Functional testing performed included leak testing, clear passage test, and clamp function test.It passed all functional tests performed, except the underwater pressure leak test where a leak was observed through the hole in tubing port.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The product did not meet product specifications for the reported problem of leak.The reported problem was verified.The assignable cause code was determined to be a hole or cut.The cause of the hole or cut was undetermined.If additional relevant information is obtained, then a follow-up mdr will be submitted.

• 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5015283
• MDR Text Key: 24289234
• Report Number: 1416980-2015-32986
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2019
• Device Catalogue Number: T5C4476
• Device Lot Number: H14L15032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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