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

Device Problems Crack (1135); Hole In Material (1293); Kinked (1339); Leak/Splash (1354)

Patient Problem Peritonitis (2252)

Event Date 03/11/2015

Event Type  Injury  

Event Description

It was reported that a patient experienced a tear in the pd transfer set which caused peritonitis coincident with peritoneal dialysis (pd) therapy.The tear in the pd transfer set was further described as a crack or leak which happened over time due to a kink.The peritonitis was manifested by a hazy bag (cloudy pd effluent) and a high white blood cell count.On the same day as onset, the patient was admitted to the hospital.On an unknown date in the same month as onset, the patient was treated for the peritonitis with daptomycin (intravenously [iv], dose and frequency not reported).On an unreported date, the patient received a new pd transfer set.Eleven days after being admitted, the patient was discharged from the hospital.Ten days after discharge, the patient was re-admitted to the hospital for the same peritonitis and discharged four days later.At the time of this report, the patient was still on the iv antibiotics and was recovering from the event.At the time of this report, dianeal therapy was ongoing.No additional information is available.

Manufacturer Narrative

(b)(4).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4773852
• MDR Text Key: 18544506
• Report Number: 1416980-2015-21485
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2015
• 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: DIANEAL PD4, 1.5%, 2.5%, 4.25%
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR