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

Catalog Number L5C4531

Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a small hole in the patient line of the homechoice cassette which resulted in a leak.This was noted during fill one of four of peritoneal dialysis therapy.The patient stated that the hole was near the patient line connector where the patient line connected to the transfer set.The patient also said that it was difficult to connect the patient line to the transfer set and they had to use excessive force.The transfer set had no damage and they have not had any issues setting up or performing therapy since.There were also no issues noted with the cassette prior to setting up.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to these reported conditions during the manufacture of this lot; however this review did find similar complaints for this lot number for the reported problem of leak.The device was not returned for analysis; therefore, no evaluation could be performed.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; mountain home AR
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; ni; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5976756
• MDR Text Key: 55628402
• Report Number: 1416980-2016-15605
• 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: Initial,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/16/2021
• Device Catalogue Number: L5C4531
• Device Lot Number: H16F16088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2016
• 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: N
• Patient Sequence Number: 1
• Treatment: HOMECHOICE
• Patient Age: 53 YR