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 Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2020

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 blood leak occurred with the combiset bloodlines during the patient¿s at-home hemodialysis (hd) treatment.The s-clamp was closed on the tubing of the combiset and the blue clamp was placed just past the s-clamp for extra strength during treatment setup.However once treatment began, blood could be visually observed within the recirculation saline line.A second blue clamp was added between the s-clamp and the original blue clamp to address the blood leak, however blood continued to bypass the clamps.It was noted by the patient that the tubing between the recirculation connector and the s-clamp is made of a hard plastic which is difficult to securely clamp.The patient completed treatment despite the leak.It was confirmed during follow-up that the patient completed treatment without experiencing a serious injury, adverse event, or requiring medical intervention.Additional information was not available upon request.The complaint device was reported to be available for return to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information: d9, h3 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.

Manufacturer Narrative

H3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During the visual inspection of the actual sample, no damage was observed such as short shots, cracks, or broken parts.During the functional test no leaks were observed in the saline line.During the evaluation of the sample, the reported issue was not confirmed.A conclusion regarding the reported issue cannot be determined.

• 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: 11263844
• MDR Text Key: 232557041
• Report Number: 8030665-2021-00136
• 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,Followup
• Report Date: 05/05/2021

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: 20AR01252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Device Age: MO
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1