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

Catalog Number 03-2722-9C

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 07/07/2023

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 clinic manager (cm) reported to fresenius that a blood leak occurred with the combiset smartech bloodlines.Additional information was provided during follow-up by a user facility registered nurse (rn).The patient had approximately 45 minutes of left of hemodialysis (hd) treatment (out of a 3.5 hour runtime) when the reported event occurred.A slow drip of blood was observed around the arterial connection to the dialyzer.The connection was tightened however the leak continued from the crit-line window.When attempting to remove the crit-line clip (clic) device, the connection snapped in half.Treatment was paused.The patient¿s blood could not be returned.The patient¿s estimated blood loss (ebl) is approximately 350 ml.The rn noted that the patient experienced a drop in blood pressure from the blood loss.The rn explained that the patient¿s blood pressure normally runs high, and the clinic has standing order in place to all patients to provide 200 ml of saline intravenously (iv) when a drop in blood pressure is experienced which was used in this case.The rn confirmed that the patient did not experience a serious injury or require medical intervention as a result of this issue.The patient ended treatment for the day with approximately 45 minutes of runtime remaining.There was no observed defect or damage noted to the bloodline prior to the reported issue.The rn confirmed the sample has been discarded and is not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Correction: d4 (expiration date), h4 plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.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

A user facility clinic manager (cm) reported to fresenius that a blood leak occurred with the combiset smartech bloodlines.Additional information was provided during follow-up by a user facility registered nurse (rn).The patient had approximately 45 minutes of left of hemodialysis (hd) treatment (out of a 3.5 hour runtime) when the reported event occurred.A slow drip of blood was observed around the arterial connection to the dialyzer.The connection was tightened however the leak continued from the crit-line window.When attempting to remove the crit-line clip (clic) device, the connection snapped in half.Treatment was paused.The patient¿s blood could not be returned.The patient¿s estimated blood loss (ebl) is approximately 350 ml.The rn noted that the patient experienced a drop in blood pressure from the blood loss.The rn explained that the patient¿s blood pressure normally runs high, and the clinic has standing order in place to all patients to provide 200 ml of saline intravenously (iv) when a drop in blood pressure is experienced which was used in this case.The rn confirmed that the patient did not experience a serious injury or require medical intervention as a result of this issue.The patient ended treatment for the day with approximately 45 minutes of runtime remaining.There was no observed defect or damage noted to the bloodline prior to the reported issue.The rn confirmed the sample has been discarded and is not available to be returned to the manufacturer for physical evaluation.

• Brand Name: COMBISET SMARTECH BLOODLINE
• 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; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 17299697
• MDR Text Key: 319699162
• Report Number: 0008030665-2023-00618
• Device Sequence Number: 1
• Product Code: FJK
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9C
• Device Lot Number: 23AR01017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2023
• 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 2008T MACHINE.; FRESENIUS 2008T MACHINE.; FRESENIUS DIALYZER.; FRESENIUS DIALYZER.
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 92 KG