MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE MTS SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 050-50758

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2017

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in progress.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

It was reported that a patient discovered a fluid leak during peritoneal dialysis therapy.The leak was further described as the patient noticed fluid leaking from the connection between the patient line of the cassette and the stay safe multi-segment dual connector.There was no report of a cycler alarm that coincided with the fluid leak.It was unknown during which phase of therapy the leak was identified.The cause of the leak was reported to be a loose connection.Upon reporting the leak, the patient was advised to start therapy over using new supplies.There was no patient injury or medical intervention required as a result of the reported leak.The supplies were not available for evaluation.Following the event, the patient was able to continue with peritoneal dialysis therapy without complication.Additional information was requested but was not available.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the lot number was not provided.Distribution records were reviewed to identify potential lots of this product shipped to the customer for the three (3) month time frame which immediately preceded the event.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.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.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: STAY SAFE MTS SET
• Type of Device: 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
• 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 Key: 7066341
• MDR Text Key: 93581256
• Report Number: 8030665-2017-01042
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100699
• UDI-Public: 00840861100699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-50758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 12/18/2017
• 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 Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 92