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 Vomiting (2144); Loss of consciousness (2418)

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility area technology operations manager (atom) reported a blood leak occurred between the combiset bloodlines near the arterial transducer connection to the thicker tubing for blood pump.The leak was visually observed and a separated connection caused a leak from the pump wheel door.The leak was noticed approximately 1 hour 49 minutes into treatment.There were no loose connections detected at the time and connections were tested prior to treatment.There was no damage or defect seen on the combiset.When the leak was noticed, the treatment was discontinued.The patient¿s estimated blood loss (ebl) was approximately 700 ml.The patient experienced a loss of consciousness after blood loss, however the patient regained consciousness and then vomited once after the rapid response.A normal saline bolus of 150 ml was administered per standing order.The patient was not admitted to the hospital and returned home that day without medical intervention.The patient was on a fresenius 2008t with bibag machine and using a fresenius dialyzer.There were no changes or a disruption in pressure that could have caused the issue.Additionally, the sample has been discarded and 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.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 area technology operations manager (atom) reported a blood leak occurred between the combiset bloodlines near the arterial transducer connection to the thicker tubing for blood pump.The leak was visually observed and a separated connection caused a leak from the pump wheel door.The leak was noticed approximately 1 hour 49 minutes into treatment.There were no loose connections detected at the time and connections were tested prior to treatment.There was no damage or defect seen on the combiset.When the leak was noticed, the treatment was discontinued.The patient¿s estimated blood loss (ebl) was approximately 700 ml.The patient experienced a loss of consciousness after blood loss, however the patient regained consciousness and then vomited once after the rapid response.A normal saline bolus of 150 ml was administered per standing order.The patient was not admitted to the hospital and returned home that day without medical intervention.The patient was on a fresenius 2008t with bibag machine and using a fresenius dialyzer.There were no changes or a disruption in pressure that could have caused the issue.Additionally, 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; 1100 e, military hwy, suite c; pharr TX 78577
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13804204
• MDR Text Key: 287398453
• Report Number: 8030665-2022-00250
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• 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: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 03-2722-9C
• Device Lot Number: 21SR01012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2021
• 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 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Age: 83 YR
• Patient Sex: Male