MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number 03-2622-3

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/09/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that air entered the combiset bloodlines through the arterial line approximately 10 minutes after the initiation of the patient's hemodialysis (hd) treatment.The machine, a fresenius 4008s machine, alarmed appropriately with an air detected message.There was no damage noticed on the bloodlines.Prime was completed during setup without issue.The patient¿s estimated blood loss (ebl) was not provided.There was no patient injury or medical intervention required as a result of this event.The patient successfully completed treatment on the same machine with new supplies.The complaint device was not returned to the manufacturer for physical evaluation.

Manufacturer Narrative

A1.

Event Description

It was reported that air entered the combiset bloodlines through the arterial line approximately 10 minutes after the initiation of the patient's hemodialysis (hd) treatment.The machine, a fresenius 4008s machine, alarmed appropriately with an air detected message.There was no damage noticed on the bloodlines.Prime was completed during setup without issue.The patient¿s estimated blood loss (ebl) was not provided.There was no patient injury or medical intervention required as a result of this event.The patient successfully completed treatment on the same machine with new supplies.The complaint device was not returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: the complaint sample was discarded and could not be returned to the manufacturer for a physical evaluation.Photographs were provided however they do not capture the reported event.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances 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.

Event Description

It was reported that air entered the combiset bloodlines through the arterial line approximately 10 minutes after the initiation of the patient's hemodialysis (hd) treatment.The machine, a fresenius 4008s machine, alarmed appropriately with an air detected message.There was no damage noticed on the bloodlines.Prime was completed during setup without issue.The patient¿s estimated blood loss (ebl) was not provided.There was no patient injury or medical intervention required as a result of this event.The patient successfully completed treatment on the same machine with new supplies.The complaint device was not returned to the manufacturer for physical evaluation.

• Brand Name: COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15602280
• MDR Text Key: 301753348
• Report Number: 0008030665-2022-01195
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100231
• UDI-Public: 00840861100231
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2022

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
• Device Operator: Health Professional
• Device Model Number: 03-2622-3
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 22CR01090
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 10/27/2022; 11/10/2022
• Supplement Dates FDA Received: 11/07/2022; 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2022
• 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
• Treatment: FRESENIUS 4008S MACHINE; FRESENIUS 4008S MACHINE; FRESENIUS 4008S MACHINE
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 89 KG