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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number 050-87216
Device Problems Contamination During Use; Use of Device Problem
Event Date 07/08/2017
Event Type  Injury  
Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, and the lot number was not able to be obtained to date. Distribution records were reviewed to identify potential lots of this product shipped to the customer over the past 3 months. The entire set of lots have been sold and distributed. Batch records for the lots identified were reviewed and confirmed there were no deviations or non-conformances during the manufacturing process. In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

 
Event Description

During follow up on an unrelated event the patient's peritoneal dialysis (pd) nurse reported the patient had been hospitalized for peritonitis. During additional follow up the nurse reported the patient was hospitalized starting on (b)(6) 2017 and discharged (b)(6) 2017. The patient's effluent culture was positive for peritonitis due to pseudomonas. More specific type was not available. The patient's nephrologist prescribed removal of pd catheter and transition to hemodialysis, which patient has done. The patient is expected to return to pd treatment in the future. The antibiotic regimen was unknown. The infection was due to a breach in aseptic technique. The patient's caregiver dropped a part of the patient's line onto the floor and then applied that same part onto the catheter. The patient was hooking up for treatment (b)(6) 2017 at the time and developed symptoms the day after. If / when patient returns to pd there will be retraining on proper technique. The patient's hospital discharge was not available. The set was not made available for evaluation.

 
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Brand NameLIBERTY CYCLER SET, SINGLE CONN./EXT. DL
Type of DeviceSYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX  88780
Manufacturer (Section G)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX  88780
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham , MA 02451
7816999499
MDR Report Key6775059
Report Number8030665-2017-00547
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 05/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/08/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device Catalogue Number050-87216
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Age mo
Event Location No Information
Date Manufacturer Received09/21/2017
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 Initial

Patient TREATMENT DATA
Date Received: 08/08/2017 Patient Sequence Number: 1
Treatment
DELFLEX PD FLUID
LIBERTY CYCLER
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