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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA MFG LIBERTY CYCLER SET, SINGLE CONN./EXT.DL

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FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA MFG LIBERTY CYCLER SET, SINGLE CONN./EXT.DL Back to Search Results
Catalog Number 050-87216
Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2015
Event Type  malfunction  
Event Description
A peritoneal dialysis pt reported that dialysis solution leaked out of his catheter.Upon follow up, the pdrn stated that leak was not coming from his pd catheter but was coming from the extension set.Pdrn stated that there was a tear in the extension set and the stay safe cap was off when the pt went into the clinic.The cap had fallen off.Prophylactic antibiotics were administered and there was no other known pt ill effect.Pt's effluent remained clear.Sample is not available for return.
 
Manufacturer Narrative
The device was not returned to the mfr for physical eval, 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 within three months of the date of the event.Batch records for the lot identified were reviewed adn confirmed there were no deviations or nonconformances during the mfg process.
 
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Brand Name
LIBERTY CYCLER SET, SINGLE CONN./EXT.DL
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA MFG
reynosa
MX 
Manufacturer (Section G)
REYNOSA PLANT
mike allen 1331
parque industrial reynosa
reynosa, tamaulipas, cp 8878 0
Manufacturer Contact
tanay taft, rn cnor
920 winter st
waltham, MA 02451
8006621237
MDR Report Key4597317
MDR Text Key5485101
Report Number8030665-2015-00109
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
PMA/PMN Number
K043363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility,Company Representative
Type of Report Initial
Report Date 02/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number050-87216
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/07/2015
Initial Date FDA Received03/05/2015
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 Sequence Number1
Treatment
PD SOLUTIONS; LIBERTY DIALYSIS CYCLER,
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