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

Catalog Number R5C4479C

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tubing from an automated peritoneal dialysis set with cassette broke ¿a few inches away¿ from the transfer set which resulted in leaking during therapy.It was reported no issues were observed during setup.The cause of the break was not reported.The patient was brought to the hospital and was administered prophylactic antibiotics as a precaution.It was reported the transfer set was changed.No further medical intervention was reported for this event.Patient outcome was not reported.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.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
• MDR Report Key: 8640758
• MDR Text Key: 146077539
• Report Number: 1416980-2019-02874
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412088433
• UDI-Public: (01)00085412088433
• Combination Product (y/n): N
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/26/2023
• Device Catalogue Number: R5C4479C
• Device Lot Number: H18K26078
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HOMECHOICE; HOMECHOICE