MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number L5C4531

Device Problems Leak/Splash (1354); Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2015

Event Type  malfunction  

Event Description

It was reported that a patient discovered a leak in the patient line of a disposable cassette.The patient was connected at the time of the event.This event occurred during initial drain of peritoneal dialysis therapy.The patient stated there was a slice in the patient line near the cassette door.The technical service representative (tsr) assisted the patient with ending therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received for evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection was performed with naked eye and magnification and cuts in the patient line tubing were found.Marks were also observed that were indicative of the pouching equipment.Clamp function test, clear passage test, and simulated therapy were performed with no issues noted.Leaking testing was performed and a leak through cuts in patient line tubing was observed.The reported condition was verified.The cause of the condition was determined to be manufacturing issue due to pouching/flow wrap equipment.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE AUTOMATED PD SET WITH CASSETTE
• 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: 4775826
• MDR Text Key: 5797302
• Report Number: 1416980-2015-21606
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: L5C4531
• Device Lot Number: H15B27036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2015
• 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
• Treatment: HOMECHOICE
• Patient Age: 61 YR