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 07/01/2021

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 hemodialysis (hd) facility administrator (fa) reported that a combi set blood leak occurred two to three minutes into a patient¿s hd treatment.The fa stated that the twister lines came apart where you twist the plastic piece that initiates the access flow.Some blood leaked onto the floor, and the separation was noticed almost immediately.The fa was unsure if there were any machine alarms.The patient was dialyzing on a fresenius 2008t machine and utilizing a fresenius optiflux dialyzer.There were no abnormal changes in pressure.Per the fa, the patient¿s blood flow rate was increased at a normal rate, to reach the prescribed blood flow rate.There were no visible defects found on the combi set prior to treatment, and there were no leaks during the priming phase.After the blood leak occurred, the treatment was paused.The patient¿s blood was not returned; estimated blood loss (ebl) was reportedly 300 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.The patient completed their treatment after being re-setup with new supplies on the same machine.The combi set was reported to be available for a manufacturer evaluation.

Manufacturer Narrative

Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no sample has been received.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.Should the sample be returned at a later date, a supplemental report will be submitted capturing the updated investigation results.

Event Description

A hemodialysis (hd) facility administrator (fa) reported that a combi set blood leak occurred two to three minutes into a patient¿s hd treatment.The fa stated that the twister lines came apart where you twist the plastic piece that initiates the access flow.Some blood leaked onto the floor, and the separation was noticed almost immediately.The fa was unsure if there were any machine alarms.The patient was dialyzing on a fresenius 2008t machine and utilizing a fresenius optiflux dialyzer.There were no abnormal changes in pressure.Per the fa, the patient¿s blood flow rate was increased at a normal rate, to reach the prescribed blood flow rate.There were no visible defects found on the combi set prior to treatment, and there were no leaks during the priming phase.After the blood leak occurred, the treatment was paused.The patient¿s blood was not returned; estimated blood loss (ebl) was reportedly 300 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.The patient completed their treatment after being re-setup with new supplies on the same machine.The combi set was reported to be available for a manufacturer evaluation.

• 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: 12160864
• MDR Text Key: 261461140
• Report Number: 8030665-2021-01141
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

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 Expiration Date: 02/29/2024
• Device Model Number: 03-2794-0
• Device Catalogue Number: 03-2794-0
• Device Lot Number: 21BR01161
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 07/29/2021
• 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: 76 YR
• Patient Weight: 120