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

Catalog Number 5C4476

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

(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 five (5) effluent sample bags leaked; further described as ¿right beside the collection port where it connects to the bag¿.The leaks were noted during unspecified steps of peritoneal dialysis therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device for three (3) events were not received for evaluation; therefore, a device analysis could not be completed.Two (2) samples were received for evaluation.A visual inspection with naked eye noted an incomplete port/flat seal at the patient connector tubing port.Functional testing, including leak testing, clear passage testing, and clamp function testing were performed; leak testing failed due to a leak through port seal at the patient connector tubing.The reported condition was verified.The direct cause of the event was determined to be manufacturing related.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: EFFLUENT SAMPLE BAG
• 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: 8668459
• MDR Text Key: 146984071
• Report Number: 1416980-2019-03069
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412007717
• UDI-Public: (01)00085412007717
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923065
• 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: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/05/2024
• Device Catalogue Number: 5C4476
• Device Lot Number: H19C05069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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