MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017); Connection Problem (2900)

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

Event Date 06/25/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).As the sample was not returned, a device analysis could not be completed.Should additional relevant information become available, a follow up report will be submitted.

Event Description

It was reported that a peritoneal dialysis (pd) patient experienced a connection issue and subsequently developed peritonitis due to the event.On an unreported date, the patient made a touch contamination when the patient¿s titanium adapter disconnected from the patient¿s transfer set.The issue was further described as ¿the plastic (of transfer set) screwing onto titanium adapter had been falling off¿, (not further specified).Subsequently the patient experienced peritonitis manifested by abdominal pain and a cloudy effluent bag.On the same day as onset, the patient was hospitalized for the event.N the same day, the patient was administered 1g of fortaz (ip) intraperitoneally once a day to treat the peritonitis.Two weeks later, treatment with fortaz was discontinued.Three days after being admitted, the patient was discharged from the hospital.At the time of this report, the peritonitis was resolving, the patient was recovering, and dianeal therapy was ongoing.Additional information was requested but is not available.

Manufacturer Narrative

Complaint no: (b)(4).Should additional relevant information become available, a follow-up will be submitted.(b)(4).

• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3972686
• MDR Text Key: 12241800
• Report Number: 1416980-2014-24976
• 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,Followup
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 08/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/03/2014
• 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; DIANEAL PD4, AMBUFLEX; MINICAP TRANSFER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR