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 11/15/2021

Event Type  malfunction  

Event Description

A hemodialysis (hd) clinic distribution center reported that a blood leak occurred at the cross threaded connection between the bloodlines and the dialyzer immediately after the initiation of hemodialysis (hd) treatment.The blood leak was visually observed as blood reached the dialyzer via the arterial line.The machine, a fresenius 4008 s machine, alarmed appropriately and the patient was using a fresenius dialyzer.Even though no loose connections were found, the leak was due to not being able to securely connect to the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 1 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The nurse stated that when the leak was noticed, the treatment was discontinued and then restarted on a different machine with new supplies.There were no changes during treatment as well as nothing noticed during priming.The nurse confirmed there were no changes or disruption in pressure that could have caused the issue or for the machine to alarm.The complaint device is available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

A hemodialysis (hd) clinic distribution center reported that a blood leak occurred at the cross threaded connection between the bloodlines and the dialyzer immediately after the initiation of hemodialysis (hd) treatment.The blood leak was visually observed as blood reached the dialyzer via the arterial line.The machine, a fresenius 4008 s machine, alarmed appropriately and the patient was using a fresenius dialyzer.Even though no loose connections were found, the leak was due to not being able to securely connect to the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 1 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The nurse stated that when the leak was noticed, the treatment was discontinued and then restarted on a different machine with new supplies.There were no changes during treatment as well as nothing noticed during priming.The nurse confirmed there were no changes or disruption in pressure that could have caused the issue or for the machine to alarm.Upon further follow up, the complaint device is not available to be 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.However, a video of the combi set connected to the machine was provided by the customer.Evidence of a blood leak was apparent in the provided video.The video shows blood leaking from the red din connector to the dialyzer.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.The reported event was confirmed based on the provided video.

Event Description

A hemodialysis (hd) clinic distribution center reported that a blood leak occurred at the cross threaded connection between the bloodlines and the dialyzer immediately after the initiation of hemodialysis (hd) treatment.The blood leak was visually observed as blood reached the dialyzer via the arterial line.The machine, a fresenius 4008 s machine, alarmed appropriately and the patient was using a fresenius dialyzer.Even though no loose connections were found, the leak was due to not being able to securely connect to the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 1 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The nurse stated that when the leak was noticed, the treatment was discontinued and then restarted on a different machine with new supplies.There were no changes during treatment as well as nothing noticed during priming.The nurse confirmed there were no changes or disruption in pressure that could have caused the issue or for the machine to alarm.Upon further follow up, the complaint device is not available to be returned to the manufacturer for physical evaluation.

Event Description

A hemodialysis (hd) clinic distribution center reported that a blood leak occurred at the cross threaded connection between the bloodlines and the dialyzer immediately after the initiation of hemodialysis (hd) treatment.The blood leak was visually observed as blood reached the dialyzer via the arterial line.The machine, a fresenius 4008 s machine, alarmed for unknown reasons and the patient was using a fresenius dialyzer.Even though no loose connections were found, the leak was due to not being able to securely connect to the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 1 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The nurse stated that when the leak was noticed, the treatment was discontinued and then restarted on a different machine with new supplies.There were no changes during treatment as well as nothing noticed during priming.The nurse confirmed there were no changes or disruption in pressure that could have caused the issue or for the machine to alarm.Upon further follow up, the complaint device is not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Correction: b5.

• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12861580
• MDR Text Key: 281157876
• Report Number: 8030665-2021-01764
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• 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: 21ER01075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• 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 4008 S MACHINE; FRESENIUS 4008 S MACHINE; FRESENIUS 4008 S MACHINE; FRESENIUS 4008 S MACHINE; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 52 KG