MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET SMARTECH BLOODLINE; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number 03-2722-9C

Device Problem Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 03/02/2022

Event Type  Death  

Event Description

It was reported via user facility medwatch (b)(4) that a patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) experienced a blood leak (venous line) during treatment.Subsequently the patient was transported via emergency medical services (ems) to the hospital, where they later expired.A review of the patient treatment record revealed the patient arrived for her regularly scheduled hd treatment on (b)(6) 2022.The patient¿s pretreatment vitals were: blood pressure (b/p) = 143/91, pulse = 93 bpm, respirations = 17, temperature = 97.5, weight = (b)(6) kgs.Additionally, the pretreatment machine checks were all completed without issue.At 1118 am the patient¿s hd treatment was initiated via a central venous catheter (cvc), at a blood flow rate of 400 ml/min.A patient connector clip (no visual defects) was applied to secure both the arterial and venous lumens of the hd catheter (not a fresenius product) to the combi-set blood lines.At 1132 am, a patient care technician responded to a machine alarm at the patient¿s station.Blood was noted on the under-pad as well as the patient's chest and abdominal area.The blood pump was immediately stopped, and the patient¿s blood was not returned due to the presence of air in the bloodlines.The estimated blood loss (>100 ml) originated from venous bloodline/venous lumen connection site.The last recorded vital signs prior to discontinuing treatment were b/p of 60/26, and a pulse of 129 bpm.The patient¿s pulse was undetectable, cardiopulmonary resuscitative (cpr) measures were initiated (included 1500 ml of normal saline and defibrillator) and ems was contacted.At 1140 am, ems arrived and assumed care of the patient.Vital signs prior to discharge were: b/p = 80/47, pulse = 81 bpm.The patient was transported to the hospital, where further unspecified interventions were provided.Although the timeline is unknown, the patient¿s family decided to change the patient¿s status to comfort care only, and they passed away at 1415 pm on (b)(6) 2022.The primary cause of death was a cardiac arrest of unknown origin, and no secondary cause was documented.Both the patient¿s esrd death notification and death certificate were unavailable during follow-up.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between hd therapy utilizing the combi set bloodlines, patient connector clip, and the serious adverse events of, blood loss, hypotension, loss of consciousness, pulselessness, and death.Causality was attributed to a separation (etiology unknown) between the custom combi set and the patient connector clip.Ensure all connections are secure prior to initiating hd therapy to prevent blood leaks, however overtightening can lead to cracks.Additionally, it should be noted the 2008t hemodialysis system may not alarm in every blood loss situation.Based on the totality of the information available, the combi-set bloodlines cannot be excluded from having a possible causal and/or contributory role in the patient¿s serious adverse events.There is currently no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction caused/contributed to the events.However, the patient was actively undergoing hd therapy when the events began.If the combi-set bloodline and patient connector clip are returned, a manufacturer evaluation may dissociate the products from having contributed to the serious adverse events.However, without knowing what caused the disconnection, this clinical investigation cannot disassociate the device from the serious adverse events.

Manufacturer Narrative

Additional information: d9, g1, h3 plant investigation: a combi set sample (arterial and venous line) was returned to the manufacturer for physical evaluation.The complaint sample was returned without its original packaging, and without the patient connector clip (hemaclip).The sample was disinfected and prepared for analysis.During disinfection of the sample, no issues were found.During the visual inspection of the sample, no defects were found.The venous end patient connector was closely inspected and found to be acceptable, with no defects such as collar or taper damage.The arterial end patient connector was received attached to a non-fresenius female connector.The male conical fitting of the venous patient connector was dimensionally inspected using an ansi male gauge and was found to be within an acceptable range.The sample was tested on a fresenius 2008k hemodialysis (hd) machine and worked as intended without any abnormalities.Upon completion of the investigation, the reported complaint could not be confirmed.

Event Description

It was reported via user facility medwatch (b)(4) that a patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) experienced a blood leak (venous line) during treatment.Subsequently the patient was transported via emergency medical services (ems) to the hospital, where they later expired.A review of the patient treatment record revealed the patient arrived for her regularly scheduled hd treatment on (b)(6) 2022.The patient¿s pretreatment vitals were: blood pressure (b/p) = 143/91, pulse = 93 bpm, respirations = 17, temperature = 97.5, weight = 48.0 kgs.Additionally, the pretreatment machine checks were all completed without issue.At 1118 am the patient¿s hd treatment was initiated via a central venous catheter (cvc), at a blood flow rate of 400 ml/min.A patient connector clip (no visual defects) was applied to secure both the arterial and venous lumens of the hd catheter (not a fresenius product) to the combi-set blood lines.At 1132 am, a patient care technician responded to a machine alarm at the patient¿s station.Blood was noted on the under-pad as well as the patient's chest and abdominal area.The blood pump was immediately stopped, and the patient¿s blood was not returned due to the presence of air in the bloodlines.The estimated blood loss (>100 ml) originated from venous bloodline/venous lumen connection site.The last recorded vital signs prior to discontinuing treatment were b/p of 60/26, and a pulse of 129 bpm.The patient¿s pulse was undetectable, cardiopulmonary resuscitative (cpr) measures were initiated (included 1500 ml of normal saline and defibrillator) and ems was contacted.At 1140 am, ems arrived and assumed care of the patient.Vital signs prior to discharge were: b/p = 80/47, pulse = 81 bpm.The patient was transported to the hospital, where further unspecified interventions were provided.Although the timeline is unknown, the patient¿s family decided to change the patient¿s status to comfort care only, and they passed away at 1415 pm on (b)(6) 2022.The primary cause of death was a cardiac arrest of unknown origin, and no secondary cause was documented.Both the patient¿s esrd death notification and death certificate were unavailable during follow-up.

Manufacturer Narrative

Additional information: d9, g1, h3.Plant investigation: a combi set sample (arterial and venous line) was returned to the manufacturer for physical evaluation.The complaint sample was returned without its original packaging, and without the patient connector clip (hemaclip).The sample was disinfected and prepared for analysis.During disinfection of the sample, no issues were found.During the visual inspection of the sample, no defects were found.The venous end patient connector was closely inspected and found to be acceptable, with no defects such as collar or taper damage.The arterial end patient connector was received attached to a non-fresenius female connector.The male conical fitting of the venous patient connector was dimensionally inspected using an ansi male gauge and was found to be within an acceptable range.The sample was tested on a fresenius 2008k hemodialysis (hd) machine and worked as intended without any abnormalities.Upon completion of the investigation, the reported complaint could not be confirmed.This report is being submit upon request to update the mfr number to 8030665-2022-00402 to align with the initial report.

Event Description

It was reported via user facility medwatch (b)(4) that a patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) experienced a blood leak (venous line) during treatment.Subsequently the patient was transported via emergency medical services (ems) to the hospital, where they later expired.A review of the patient treatment record revealed the patient arrived for her regularly scheduled hd treatment on (b)(6) 2022.The patient's pretreatment vitals were: blood pressure (b/p) = 143/91, pulse = 93 bpm, respirations = 17, temperature = 97.5, weight = 48.0 kgs.Additionally, the pretreatment machine checks were all completed without issue.At 1118 am the patient's hd treatment was initiated via a central venous catheter (cvc), at a blood flow rate of 400 ml/min.A patient connector clip (no visual defects) was applied to secure both the arterial and venous lumens of the hd catheter (not a fresenius product) to the combi-set blood lines.At 1132 am, a patient care technician responded to a machine alarm at the patient's station.Blood was noted on the under-pad as well as the patient's chest and abdominal area.The blood pump was immediately stopped, and the patient's blood was not returned due to the presence of air in the bloodlines.The estimated blood loss (>100 ml) originated from venous bloodline/venous lumen connection site.The last recorded vital signs prior to discontinuing treatment were b/p of 60/26, and a pulse of 129 bpm.The patient's pulse was undetectable, cardiopulmonary resuscitative (cpr) measures were initiated (included 1500 ml of normal saline and defibrillator) and ems was contacted.At 1140 am, ems arrived and assumed care of the patient.Vital signs prior to discharge were: b/p = 80/47, pulse = 81 bpm.The patient was transported to the hospital, where further unspecified interventions were provided.Although the timeline is unknown, the patient's family decided to change the patient's status to comfort care only, and they passed away at 1415 pm on (b)(6) 2022.The primary cause of death was a cardiac arrest of unknown origin, and no secondary cause was documented.Both the patient's esrd death notification and death certificate were unavailable during follow-up.

• Brand Name: COMBISET SMARTECH BLOODLINE
• 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
• 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 14018611
• MDR Text Key: 288650180
• Report Number: 8030665-2022-00402
• Device Sequence Number: 1
• Product Code: KOC
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 03-2722-9C
• Device Lot Number: 21CR01248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• 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 HEMACLIP.; FRESENIUS HEMACLIP.
• Patient Outcome(s): Hospitalization; Required Intervention; Death
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White