MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Device Problem Material Separation (1562)

Patient Problem Peritonitis (2252)

Event Date 02/14/2014

Event Type  Injury  

Event Description

It was reported that the spike connector was separated from the spike of the transfer set during use.It was reported that the patient experienced peritonitis.It was reported that the patient was hospitalized for the event but it was not reported if treatment occurred.At the time of the report, it was not reported if the patient had recovered from the event.Additional information was requested, but is not available at this time.

Manufacturer Narrative

(b)(4).As the transfer set was not returned and the lot number is unknown, a device analysis cannot be completed.If there is any further relevant information from that review, a supplemental medwatch will be filed.

• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• 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: 3675487
• MDR Text Key: 20108715
• Report Number: 1416980-2014-08316
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2014
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR