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

Catalog Number L5C4531

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that particulate matter (pm) was identified on a homechoice cassette.The pm was further described as tiny blue plastic.The pm was discovered prior to patient use.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.A visual inspection with naked eye found one piece of loose, blue particulate matter observed inside the sealed cassette.The disposable device was dry, unused, with caps and tape in place.The reported issue was verified.The cause of the event was determined to be manufacturing related.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 - MOUNTAIN HOME; mountain home AR
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8089971
• MDR Text Key: 127936420
• Report Number: 1416980-2018-07375
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412090078
• UDI-Public: (01)00085412090078
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/29/2023
• Device Catalogue Number: L5C4531
• Device Lot Number: H18D29050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2018
• 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
• Treatment: HOMECHOICE
• Patient Age: 29 YR