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

Catalog Number L5C4531

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: should additional relevant information become available, a follow-up report will be submitted.

Event Description

It was reported that a bag fell and became un-spiked from the cassette line during dwell two on the home choice (hc).The home patient (hp) was connected at the time of the event.The technical service representative (tsr) assisted the hp to end therapy and removed the supplies.No patient injury or medical intervention was indicated as a result of this event.No additional information is available.

Manufacturer Narrative

(b)(4).As the cassette was not returned and the lot number is unknown, a device analysis cannot 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; 1900 n highway 201; mountain home AR 72653
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3612804
• MDR Text Key: 12143308
• Report Number: 1416980-2014-03790
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: L5C4531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2014
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: HOMECHOICE
• Patient Age: 77 YR