MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Device Problems Leak/Splash (1354); Material Rupture (1546)

Patient Problems Abdominal Pain (1685); Peritonitis (2252)

Event Date 12/07/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned and the product code and lot number are unknown, therefore, a device analysis cannot be completed.The cause is undetermined.Should additional relevant information become available, a follow-up will be submitted.

Event Description

It was reported that a patient experienced a ruptured cassette line which caused peritonitis coincident with automated peritoneal dialysis (apd) therapy.On an unreported date, the patient experienced a rupture in the patient line of a peritoneal dialysis (pd) cassette (no further detail was provided).Subsequently, the patient experienced peritonitis manifested by abdominal pain, not feeling well, elevated white blood cell count, and cloudy effluent.On the same day as peritonitis onset, the patient was hospitalized for the event.On the same day, the patient began treatment for the peritonitis with vancomycin (2 grams, weekly) intraperitoneally.On an unknown date, the patient was treated for the peritonitis with (cipro) ciprofloxacin (500 milligrams daily for 14 days) orally.At the time of this report, the vancomycin and cipro therapies were ongoing.Five days after being admitted to the hospital, the patient was discharged.At the time of this report, the peritonitis was resolving, the patient was recovering from the event, and dianeal therapy was ongoing.No additional information is available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

• 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4393278
• MDR Text Key: 12880174
• Report Number: 1416980-2015-00745
• Device Sequence Number: 1
• Product Code: FKX
• 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,Followup
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• 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: 01/16/2015
• 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: TRANSFER SET, TITANIUM ADAPTER, MINICAP; DIANEAL PD4, 2.5% AMBUFLEX, HOMECHOICE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR