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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2021

Event Type  malfunction  

Event Description

A user facility administrator reported a blood leak that occurred at the beginning of the patient¿s hemodialysis (hd) treatment.The blood leak was visually observed where the crit line is connected to the venous line of the combiset and was dripping onto the floor.There was no damage noticed on either the combiset or the dialyzer.The patient care technician (pct) stated that the leak was due to a potential defect in the opening on the combiset, however there were no loose connections.The pct confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The pct stated that the patient was on a fresenius 2008t machine (serial number and catalog number unknown), which did not alarm, and using a fresenius dialyzer (180nre lot number unknown).The pct stated that the blood was returned to the patient and the patient¿s estimated blood loss (ebl) was approximately 5 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient successfully completed treatment on the same machine with new supplies.The pct reported nothing was noticed during priming and there were no changes or disruptions in pressure that could have caused the issue.The complaint device was discarded and is not 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

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 administrator reported a blood leak that occurred at the beginning of the patient¿s hemodialysis (hd) treatment.The blood leak was visually observed where the crit line is connected to the venous line of the combiset and was dripping onto the floor.There was no damage noticed on either the combiset or the dialyzer.The patient care technician (pct) stated that the leak was due to a potential defect in the opening on the combiset, however there were no loose connections.The pct confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The pct stated that the patient was on a fresenius 2008t machine (serial number and catalog number unknown), which did not alarm, and using a fresenius dialyzer (180nre lot number unknown).The pct stated that the blood was returned to the patient and the patient¿s estimated blood loss (ebl) was approximately 5 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient successfully completed treatment on the same machine with new supplies.The pct reported nothing was noticed during priming and there were no changes or disruptions in pressure that could have caused the issue.The complaint device was 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: 13090668
• MDR Text Key: 285466328
• Report Number: 8030665-2021-01913
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 03-2722-9C
• Device Lot Number: 21NR01195
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 47 KG