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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, DUAL PATIENT CONNECT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number 050-87212
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Peritonitis (2252)
Event Date 07/01/2019
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A peritoneal dialysis (pd) patient reported that they were hospitalized for peritonitis.Upon follow up with the patient¿s peritoneal dialysis nurse (pdrn), it was reported that the patient was hospitalization from (b)(6) 2019.A peritoneal effluent fluid culture and a white blood cell (wbc) count were obtained (date not provided) and identified a gram-negative klebsiella pneumoniae and an elevated count of 21 (unit not provided), respectively.The patient was initially treated with intraperitoneal (ip) vancomycin and ceftazidime (dosages, frequency and durations not provided).However, the vancomycin was discontinued when the culture results were released.The patient underwent pd therapy while hospitalized and continues to undergo pd therapy post discharge and he is asymptomatic and recovering.It was reported that the source of contamination was from the patient's bowels and was unrelated to any fresenius products.
 
Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
 
Manufacturer Narrative
Corrected information: clinical investigation:a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, liberty cycler set and the adverse event of peritonitis, which warranted hospitalization and antibiotic therapy.Per the pdrn, the source of the peritonitis was the patient¿s bowels.Klebsiella pneumoniae is normal flora of the human mouth and intestine (2,3).The pdrn stated the event was unrelated to any fresenius device(s) or product(s).Therefore, based on the information available, the liberty select cycler and liberty cycler set can be disassociated as there is no allegation or objective evidence indicating a liberty select cycler product deficiency or malfunction caused or contributed to the event.It is well established those individuals undergoing pd therapy are at high risk for infections of the peritoneum (1).Should additional information become available, the need for a clinical investigation will be re-evaluated accordingly.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
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Brand Name
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX  88780
MDR Report Key8839648
MDR Text Key152617044
Report Number8030665-2019-01173
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00840861100736
UDI-Public00840861100736
Combination Product (y/n)N
PMA/PMN Number
K043363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup
Report Date 09/03/2019
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? No
Device Operator Lay User/Patient
Device Catalogue Number050-87212
Was Device Available for Evaluation? No
Device Age MO
Initial Date Manufacturer Received 07/29/2019
Initial Date FDA Received07/29/2019
Supplement Dates Manufacturer Received07/29/2019
08/14/2019
Supplement Dates FDA Received07/29/2019
09/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DELFLEX PD FLUID; LIBERTY SELECT CYCLER
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age50 YR
Patient Weight119
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