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 Hemorrhage/Bleeding (1888)

Event Date 10/31/2023

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 biomedical technician (biomed) reported to fresenius that a tear was found in the combiset smartech bloodlines during a patient's hemodiaylsis (hd) treatment.Additional information was obtained during follow-up with the facility administrator (fa).Blood was visually observed splattering from the blood pump tubing segment of the bloodlines approximately 20 minutes prior to completion of 4-hour hemodialysis (hd) treatment on a 2008t machine.Treatment was paused.The patient¿s blood was returned.The patient¿s estimated blood loss was approximately 10 ml.The patient did not experience a serious injury or require medical intervention.Treatment ended early for the day.Upon closer inspection a tear was identified in the blood pump tubing segment of the blood lines.No defect or damage was noted to the bloodlines prior to the occurrence of the reported issue.The blood pump on the 2008t machine was inspected and no issues were identified.The sample was discarded and is not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: the complaint product sample was not provided for evaluation.However, a photograph of the alleged malfunction was received from the customer.According with the photograph received, it can be observed a tear in the blood pump tubing.The alleged failure mode was confirmed; a tear was observed according with the photo received from the customer.The probable cause of the reported issue has been traced to a manufacturing and/or production issue.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.

Event Description

A user facility biomedical technician (biomed) reported to fresenius that a tear was found in the combiset smartech bloodlines during a patient's hemodiaylsis (hd) treatment.Additional information was obtained during follow-up with the facility administrator (fa).Blood was visually observed splattering from the blood pump tubing segment of the bloodlines approximately 20 minutes prior to completion of 4-hour hemodialysis (hd) treatment on a 2008t machine.Treatment was paused.The patient¿s blood was returned.The patient¿s estimated blood loss was approximately 10 ml.The patient did not experience a serious injury or require medical intervention.Treatment ended early for the day.Upon closer inspection a tear was identified in the blood pump tubing segment of the blood lines.No defect or damage was noted to the bloodlines prior to the occurrence of the reported issue.The blood pump on the 2008t machine was inspected and no issues were identified.The sample was discarded and is not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

H10 (plant investigation - typographical errors as well as product name) plant investigation: the complaint product sample was not provided for evaluation.However, a photograph of the alleged malfunction was received from the customer.According with the photograph received, a tear can be observed in the blood pump tubing.The alleged failure mode was confirmed; a tear was observed according with the photo received from the customer.The probable cause of the reported issue has been traced to a manufacturing and/or production issue.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius combiset bloodlines shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.

Event Description

A user facility biomedical technician (biomed) reported to fresenius that a tear was found in the combiset smartech bloodlines during a patient's hemodiaylsis (hd) treatment.Additional information was obtained during follow-up with the facility administrator (fa).Blood was visually observed splattering from the blood pump tubing segment of the bloodlines approximately 20 minutes prior to completion of 4-hour hemodialysis (hd) treatment on a 2008t machine.Treatment was paused.The patient¿s blood was returned.The patient¿s estimated blood loss was approximately 10 ml.The patient did not experience a serious injury or require medical intervention.Treatment ended early for the day.Upon closer inspection a tear was identified in the blood pump tubing segment of the blood lines.No defect or damage was noted to the bloodlines prior to the occurrence of the reported issue.The blood pump on the 2008t machine was inspected and no issues were identified.The sample 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; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18095551
• MDR Text Key: 327704197
• Report Number: 0008030665-2023-01012
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 2008T MACHINE.; FRESENIUS DIALYZER.; FRESENIUS DIALYZER.; FRESENIUS DIALYZER.
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 106 KG