MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. HOME HEMO COMBI SET FOR CANADA; HEMODIALYSIS SYSTEM FOR HOME USE

Catalog Number 03-2932-6

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported that a leak occurred with the combiset bloodlines during the patient¿s at-home hemodialysis (hd) treatment.It was reported that saline entered the bloodline from the saline line, even though the s-clamp and the blue clamp were used to secure the tubing.It was not initially reported that there was a defect or damage seen on the combiset.The patient stopped treatment and discarded the combiset.The blood inside of the circuit at the time that treatment was paused was not returned to the patient.The estimated blood loss (ebl) could not be provided.The patient was able to continue treatment with a new combiset.It was confirmed during follow-up that the patient did not experience an injury, adverse event, or require medical intervention as a result of this treatment.Additional information was not available upon request.The complaint device was not returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformance's or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review 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: HOME HEMO COMBI SET FOR CANADA
• Type of Device: HEMODIALYSIS SYSTEM FOR HOME USE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 11263898
• MDR Text Key: 232559436
• Report Number: 8030665-2021-00138
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,user facilit
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 03-2932-6
• Device Lot Number: 20AR01804
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1