MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE / LUER CATHETER EXT. 6IN; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	050-95013
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak during their pd treatment.The patient reported receiving a patient line is blocked (soft alarm) during drain 5 of 6 of treatment.The patient reported that the patient line extension came off and they put it back together, however their bed got wet.The technical support representative assisted the patient is cancelling their treatment and advised to follow up with their peritoneal dialysis nurse (pdrn).Upon follow up, the pdrn stated that the patient became disconnected from the catheter extension set to the catheter, resulting in the leak reported.The patient came to the clinic and had their catheter extension set, a fresenius product, replaced.The lot number of the catheter extension set that was used was unknown.The patient returned to the clinic after a week for a peritonitis protocol after the disconnection, which is an effluent culture, which came back negative.The patient was prescribed prophylactic antibiotics (type, dose, route, duration not provided) after the event per clinic procedure.Despite the prophylactic antibiotics, that there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.The patient is reported to be doing well and continuing with their peritoneal dialysis treatment.There were no samples available to be returned to the manufacturer for physical evaluation.
Additional 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 stay safe / luer catheter extension 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.

• Brand Name: STAY SAFE / LUER CATHETER EXT. 6IN
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 8429218
• Report Number: 8030665-2019-00454
• Device Sequence Number: 1628328
• Product Code: KDI
• UDI-Device Identifier: 00840861100804
• UDI-Public: 00840861100804
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K904806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-95013
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; LIBERTY CYCLER; LIBERTY CYCLER SET; DELFLEX PD FLUID; LIBERTY CYCLER; LIBERTY CYCLER SET
• Patient Age: 77 YR
• Patient Weight: 79