MAUDE Adverse Event Report: BAXTER HEALTHCARE - CLEVELAND MINICAP; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 5C4466P

Device Problems Contamination (1120); Cut In Material (2454)

Patient Problem Peritonitis (2252)

Event Date 02/09/2014

Event Type  Injury  

Event Description

This is report 2 of 4 involved in this event.This is a report of a patient who experienced and was hospitalized for peritonitis coincident with therapy for peritoneal dialysis.Therapy was ongoing.The patient was treated with gentamycin 40-60 mg intraperitoneally (ip) nightly and vancomycin 2 gm weekly ip for the event.A week later, the patient¿s catheter was accidentally cut resulting in further contamination.The catheter was repaired and the patient was discharged from the hospital and reported to have recovered from the events.No additional information is available at this time.

Manufacturer Narrative

(b)(4).A batch review of potentially associated lot number gd896126 involved in this event will be performed.Should relevant additional information become available pertaining to the reported event, a follow-up report will be submitted.This is the same patient as (b)(4).

Manufacturer Narrative

(b)(4).A batch review was conducted and there were no issues detected during manufacturing process.As the sample was not available, an evaluation could not be performed.Should additional relevant information become available, a follow-up report will be submitted.

• Brand Name: MINICAP
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - CLEVELAND; 911 highway 61 north po box 1; cleveland MS 38732
• Manufacturer (Section G): BAXTER HEALTHCARE - CLEVELAND; 911 highway 61 north po box 1; cleveland MS 38732
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3679228
• MDR Text Key: 4243939
• Report Number: 1416980-2014-08591
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K895631
• 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: 02/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C4466P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2014
• 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 AUTOMATED PD SET WITH CASSETTE; 2.5% DIANEAL PD4 AMBUFLEX; 1.5% DIANEAL PD4 ULTRABAG, MINICAP TRANSFER SET; HOMECHOICE, 4.25% DIANEAL PD4 AMBUFLEX, FLEXICAP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR