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

Catalog Number MRM4431P

Device Problems Crack (1135); Fluid/Blood Leak (1250); Material Rupture (1546); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2019

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 (hc) cassette ruptured which caused an unspecified hc alarm.This occurred during an unspecified step of peritoneal dialysis therapy.During trouble shooting, the cassette was inspected and a rupture was found, further described as it was ''cracked in the border''.There was no patient injury or medical intervention associated with this event.No additional information was available.

Manufacturer Narrative

Additional information: the actual device was not available; however, two photographs of the sample were provided for evaluation.Due to the quality and detail of the pictures, it was not possible to identify the rupture of the cassette.The reported condition could not be verified through photo inspection.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: HOMECHOICE AUTOMATED PD SET WITH CASSETTE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - CALI; cali
• Manufacturer (Section G): BAXTER HEALTHCARE - CALI; calle 36 no. 2c-22; apartado aero 2446; cali ; CO
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8560606
• MDR Text Key: 144134206
• Report Number: 1416980-2019-02380
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 07707141305201
• UDI-Public: (01)07707141305201
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

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 Expiration Date: 01/31/2024
• Device Catalogue Number: MRM4431P
• Device Lot Number: SE19AD0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2019
• 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