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

Device Problems Detachment Of Device Component (1104); Contamination (1120)

Patient Problem Peritonitis (2252)

Event Date 06/30/2014

Event Type  Injury  

Event Description

It was reported a patient experienced a connection issue coincident with peritoneal dialysis (pd) therapy.It was reported the transfer set ¿came apart¿ from the titanium adapter and the patient continued the exchange then subsequently acquired peritonitis manifested by cloudy fluid.The same day as the peritonitis onset the patient was treated with intraperitoneal (ip) vancomycin (dose and frequency not reported).The cause of the peritonitis was the transfer set ¿came apart¿ from the titanium adapter.The patient experienced a breach in aseptic technique as he ¿stuck his finger over the end of the catheter¿ when it came apart.It was reported the transfer set had no visible damage.It was reported the patient was not hospitalized for the event.On an unreported date, the patient was retrained on proper aseptic technique.Pd therapy was ongoing.At the time of this report, the patient was recovered from this peritonitis event.No additional information is available.This is report 1 of 2 involved in this peritonitis event.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.This report references the same patient as (b)(4).

Manufacturer Narrative

(b)(4).As the sample was not returned and the lot number is unknown, a device analysis cannot 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
• Manufacturer (Section G): BAXTER HEALTHCARE
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3961766
• MDR Text Key: 4557323
• Report Number: 1416980-2014-24483
• 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: 07/02/2014

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: 09/24/2014
• Initial Date FDA Received: 07/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/17/2014
• 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: EXTRANEAL SOLUTION, TITANIUM ADAPTER; DIANEAL PD4 LOW CALCIUM 1.5% AND 2.5% SOLUTION
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR