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); Torn Material (3024)

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

Event Date 08/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of the cassette was leaking during peritoneal dialysis therapy on the homechoice.The care giver reported that there were five tears in the tubing and described them as v-shaped cuts.There was no patient injury or medical intervention reported.However, the patient received prophylactic antibiotics added to the dialysis bag.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received for evaluation.A visual inspection with magnification was performed and found cuts in the tubing.Functional testing of the device included leak testing, and clear passage testing.Functional tests found leaks through cuts in tubing. a batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.The reported issue was verified and the cause of the leak was determined to be due to tubing holes.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: 5046521
• MDR Text Key: 25301293
• Report Number: 1416980-2015-34419
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: L5C4531
• Device Lot Number: H15D23106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2015
• 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
• Patient Age: 63 YR