MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET ACCESS FLOW REVERSE CON TWISTER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Model Number 03-2794-0

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/11/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility biomedical technician (biomed) reported that a blood clotting event occurred while using the combi set access flow reverse con twister.Additional information was obtained through follow-up with the facility administrator (fa) of the unit.The fa reported that towards the end of a patient¿s hemodialysis (hd) treatment, the hd machine alarmed with high arterial pressure.The fa reported that the lines clotted before the staff was able to return the patient¿s blood.The patient¿s estimated blood loss (ebl) was 250 ml.The fa confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.Per the fa, there was nothing unusual noted during the priming phase.There were no leaks or changes in pressure, and all connections were confirmed to be secure.The fa stated there was nothing wrong with the hd machine.Following the event, the machine underwent and passed all testing.The fa stated the machine was not removed from service and has continued to be used without further problems.The combi set was not available to be returned for manufacturer evaluation as it was reportedly discarded; however, it was reported that a companion sample was available to be returned for testing.

Manufacturer Narrative

Plant investigation: a companion sample from the reported lot was returned to the manufacturer for physical evaluation.There were no abnormalities detected during the visual inspection.No damage, kinks, or malformations were found on the returned companion sample.All bonds were closely examined and found to be properly assembled.The sample was then tested on a hemodialysis machine; the device worked as intended without any abnormalities.There were no air bubbles inside the system, no leaks, and no level variation in the venous or arterial chambers.Additionally, there were no alarms.A device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.No nonconformance reports or other abnormalities during the assembly of this lot were found.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.No problems were detected during evaluation of the returned sample.The investigation into the complaint was not able to confirm the reported event.

Event Description

A user facility biomedical technician (biomed) reported that a blood clotting event occurred while using the combi set access flow reverse con twister.Additional information was obtained through follow-up with the facility administrator (fa) of the unit.The fa reported that towards the end of a patient¿s hemodialysis (hd) treatment, the hd machine alarmed with high arterial pressure.The fa reported that the lines clotted before the staff was able to return the patient¿s blood.The patient¿s estimated blood loss (ebl) was 250 ml.The fa confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.Per the fa, there was nothing unusual noted during the priming phase.There were no leaks or changes in pressure, and all connections were confirmed to be secure.The fa stated there was nothing wrong with the hd machine.Following the event, the machine underwent and passed all testing.The fa stated the machine was not removed from service and has continued to be used without further problems.The combi set was not available to be returned for manufacturer evaluation as it was reportedly discarded; however, it was reported that a companion sample was available to be returned for testing.

• Brand Name: COMBISET ACCESS FLOW REVERSE CON TWISTER
• 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
• MDR Report Key: 12565553
• MDR Text Key: 274452282
• Report Number: 8030665-2021-01538
• Device Sequence Number: 1
• Product Code: KOC
• UDI-Device Identifier: 00840861100316
• UDI-Public: 00840861100316
• Combination Product (y/n): N
• PMA/PMN Number: K022536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 03-2794-0
• Device Catalogue Number: 03-2794-0
• Device Lot Number: 20ER01179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Device Age: MO
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 65 YR
• Patient Weight: 83