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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 08/02/2017
Event Type  Injury  
Manufacturer Narrative

A temporal association exists between pd therapy with fresenius products and the patient experiencing drain complications, abdominal pain, cloudy pd effluent and subsequent diagnosis of escherichia coli peritonitis (without reported hospitalization). At the time of this clinical investigation, there is no documentation in the complaint file that indicates a causal relationship between fresenius products and the patient¿s peritonitis event. The etiology of peritonitis is likely related to a breach in aseptic technique during ccpd treatment at home (reusing ccpd treatment supplies) as reported by the pd nurse. Pd therapy was continuing without reported further issues at the time of this report. A follow up will be submitted following evaluation.

 
Event Description

A peritoneal dialysis patient called in for technical assistance. During the troubleshooting the patient reported that she had canceled out of a previous treatment and reset up using the same supplies even though the cones of the supply bags had been broken. The patient also reported feeling pain in her abdomen. The patient was advised to stop treatment and inform her nurse. During follow up on (b)(6)2017, it was reported the patient was seen in the peritoneal dialysis (pd) clinic with cloudy pd effluent and observable fibrin. A pd effluent culture was performed revealing a white blood cell (wbc) count of 442 and growth of escherichia coli. On (b)(6)2017, the patient was diagnosed with peritonitis and was treated with ceftazidime (unknown dose, route, frequency and duration). The pd nurse reported the patient's peritonitis event did not require inpatient hospitalization and the patient has recovered continuing on pd treatment without reports of further issues. Additionally, the pd nurse stated the peritonitis event was caused by the patient's breach in aseptic technique during pd at home treatment when reportedly reusing the pd treatment supplies. As a result, the pd nurse stated the patient. Will have re-training on aseptic technique during pd. The set was discarded.

 
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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 Key6836635
Report Number8030665-2017-00634
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation PATIENT
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 Received08/31/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device Catalogue Number050-87216
Device LOT Number17CR08153
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Device Age mo
Event Location No Information
Date Manufacturer Received09/18/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/09/2017
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: 08/31/2017 Patient Sequence Number: 1
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