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

Catalog Number BBC8314P

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a homechoice cassette was leaking from a rupture in the patient line of the cassette during fill one of five.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

One actual device and twelve (12) retention samples were received for evaluation.A batch review was conducted and there were no deviations found related to the reported condition during the manufacture of this lot.A visual inspection of the actual sample was performed with the naked eye and a cut in the tubing was noted.A visual inspection was performed to the primary package finding that it also presents a cut.The position of the cut in the primary package matches with the position of the cut in the patient line.An integrity test was performed to the actual sample, obtaining unsatisfactory results, the leak was detected.The reported condition was verified.The assignable cause of the leak was determined to be a cut in the tubing of the patient line.An assignable cause of the cut could not be determined.A visual inspection of the twelve (12) retention samples was performed and there were no visually detectable perforations or damage.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 - ATLACOMULCO; altacomulco
• Manufacturer (Section G): BAXTER HEALTHCARE - ATLACOMULCO; av. ing. salvador sanchez; colin no. 9; atlacomulco CP504 50; MX CP50450
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6949822
• MDR Text Key: 89742710
• Report Number: 1416980-2017-08311
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NI
• 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: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: BBC8314P
• Device Lot Number: 01YGHC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 10/30/2017
• Supplement Dates FDA Received: 11/06/2017
• 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