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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number L5C4531
Device Problems Cap; Cassette; Tube; Bent; Break; Detachment Of Device Component; Improper or Incorrect Procedure or Method
Event Type  Injury  
Manufacturer Narrative

Date of event: the peritonitis occurred on an unspecified date "three weeks ago". This report is for a breach in aseptic technique which resulted in peritonitis. Per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy. A review of the label for the product family will be conducted. 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.

 
Event Description

A peritoneal dialysis (pd) patient experienced a breach in aseptic technique which resulted in peritonitis. The patient reported the pull ring cap came off the patient line while walking to the restroom and due to the tangled tubing of the cassettes, there was a touch contamination that led to peritonitis. The breach in aseptic technique was further described by the pd nurse as a touch contamination, as the patient frequently touches their face, body, and hair and then handles their pd disposables. It was not reported if the patient was hospitalized for the peritonitis event. Treatment was not reported. Action taken with therapy was not reported. At the time of this report the patient outcome was not reported. It was not reported if the patient was retrained on the proper aseptic technique. No additional information is available.

 
Manufacturer Narrative

(b)(4). A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.

 
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Brand NameHOMECHOICE AUTOMATED PD SET WITH CASSETTE
Type of DeviceSYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
BAXTER HEALTHCARE - MOUNTAIN HOME
mountain home AR
Manufacturer (Section G)
BAXTER HEALTHCARE - MOUNTAIN HOME
1900 n highway 201
mountain home AR 72653
Manufacturer Contact
25212 w. illinois route 120
round lake , IL 60073
2242702068
MDR Report Key7212716
Report Number1416980-2018-00310
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 02/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/23/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue NumberL5C4531
Device LOT NumberH17J30115
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2018
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

Patient TREATMENT DATA
Date Received: 01/23/2018 Patient Sequence Number: 1
Treatment
HOMECHOICE
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