MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET SMARTECH BLOODLINE; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number 03-2722-9C

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) reviews are still in process.A supplemental mdr will be submitted upon completion of this activity.Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.An sap shipping history search was performed to identify the lot numbers that have been shipped to this account for the three (3) month time frame which immediately preceded the event occurrence date.According to the sap system, the entire set of lots have been sold and distributed.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.

Event Description

A user facility biomedical technician (biomed) reported that a patient¿s blood could not be rinsed back from the smartech combi set arterial line at the end of treatment.It is unknown how much blood loss this resulted in.The biomed stated that it acts like it has a backflow preventer.The biomed stated it has happened multiple times at this clinic.There was no patient harm or adverse event reported at intake.Multiple attempts to obtain additional information have been unsuccessful.

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 account for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius combi set bloodlines 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.

Event Description

A user facility biomedical technician (biomed) reported that a patient¿s blood could not be rinsed back from the smartech combi set arterial line at the end of treatment.It is unknown how much blood loss this resulted in.The biomed stated that it acts like it has a backflow preventer.The biomed stated it has happened multiple times at this clinic.There was no patient harm or adverse event reported at intake.Multiple attempts to obtain additional information have been unsuccessful.

• Brand Name: COMBISET SMARTECH BLOODLINE
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• 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.; director, quality systems; 1100 e, military hwy, suite c; pharr TX 78577
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 12844935
• MDR Text Key: 282259467
• Report Number: 8030665-2021-01752
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/24/2021
• 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