MAUDE Adverse Event Report: BAXTER HEALTHCARE- SINGAPORE HOMECHOICE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 5C4471

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2016

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 device presented a damaged cable.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The device was not returned for analysis; therefore, no evaluation could be performed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was returned and evaluated.Method codes had additional method codes added, but conclusion code was replaced and results code was replaced.The device was received for evaluation.Visual inspection was performed and no issues were noted.The device passed all functional testing.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.The reported problem of a damaged power cord was not verified during the device evaluation.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE- SINGAPORE; singapore
• Manufacturer (Section G): BAXTER HEALTHCARE-SINGAPORE; 2 woodlands industrial; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6126031
• MDR Text Key: 60862247
• Report Number: 1416980-2016-17607
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C4471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1