MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET ACCESS FLOW REVERSE CON TWISTER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number 03-2794-0

Device Problems Failure To Adhere Or Bond (1031); Connection Problem (2900)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Hypovolemia (2243); Blood Loss (2597)

Event Date 12/06/2017

Event Type  Death  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

Approximately 2 1/4 hours into a scheduled three hour hemodialysis treatment, a patient was found non-responsive.Most recent vs (10 minutes prior).The venous line was noted to be disconnected with the hemaclip still in place.The venous bloodline and central venous catheter venous lines were clamped.The blood pump was stopped and the patient was placed on the left side, where oxygen was applied and 911 was called.An automated external defibrillator (aed) was applied and cardiopulmonary resuscitation was initiated.A total of 400ml normal saline was infused.Two shocks were administered with aed.Patient was transported to the hospital via emergency medical services (ems) where she later died.Additional information and medical records were requested.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation, and the lot number was not able to be obtained to date.Therefore a search on the shipment system was performed of the lots delivered to the facility, with a time frame of three months before of the event date from (b)(6) 2017 thru (b)(6) 2017; however no information was found from the code number 03-2794-0 or bloodline device shipped to the facility.Consequently no product will be returned from the distribution center to be analyzed since the lot number is unknown and no information was found on the shipment system from this customer regarding to the code number 03-2794-0 or bloodline device shipped to the facility.No device history records review was performed since the lot number is unknown and no information was found on the sap system from this customer related to the code number 03-2794-0 or bloodline device shipped to the facility.

Event Description

Information in the complaint file was reviewed by a pots market surveillance clinician.On 12/20/2017, a copy of a voluntary medwatch was received from a hemodialysis (hd) clinic that was previously submitted to the fda for this (b)(6) female end stage renal disease (esrd) patient on in-center hd for renal replacement therapy (rrt) to make notification that the patient expired during hd treatment.On (b)(6) 2017, approximately 2 ¼ hours into a scheduled 3 hour hd treatment, the patient was found unresponsive.The venous bloodline was noted to be disconnected from the tunneled jugular central venous catheter (not a fresenius product) with the hemaclip still in place.The patient was last checked 10 minutes prior to the patient being found unresponsive with a blood pressure 141/54 and pulse 98.The venous bloodline and central venous catheter line were then clamped and the blood pump stopped.The patient was placed on her left side, oxygen was applied and 911 was called.The automated external defibrillator (aed) was applied and cardiopulmonary resuscitation (cpr) was initiated.A total of 400ml normal saline was infused (unknown intravenous (iv) site) and two shocks were administered via aed (unknown rhythm).It is unknown what additional resuscitative efforts were performed.The patient was transported to the hospital via emergency medical services (ems) where she later expired.The problem codes listed on the medwatch are cardiopulmonary arrest, blood loss and hypovolemia.Additional information was obtained during a follow up phone call on 01/16/2018 with the hd center clinic manager.Per the manager, the patient¿s access site was not covered and the staff did not manipulate the bloodlines.It is unknown how the bloodline became detached, but the manager states that there is a ¿possibility the patient may have manipulated and disconnected the bloodlines¿.The machine did alarm once the patient became unresponsive.The patient¿s estimated blood loss is 500-1000ml, but difficult to determine as saline was administered.There was no reported malfunction or defect with the bloodline or hemaclip and the machine was pulled from service and put through several tests with no issues found and put back into service.It was unknown what make of catheter was being utilized.No additional information was available at this time.

Manufacturer Narrative

Conclusion: a temporal relationship with the adverse events of the patient¿s blood loss, hypovolemia and cardiopulmonary arrest and eventual death and the fresenius blood lines and hemaclip exist.However, there is no documentation of any defects at the connection site of the venous blood line to the catheter or any other venous blood line issues leading up to the event that would cause the disconnection.It is unknown what may have occurred to cause the catheter and venous blood line to become unsecure two and one quarter hours after the initiation of hd therapy.Reportedly, there was a hemaclip placed on the venous line, but it is unknown what make of catheter was utilized and if it was compatible with the hemaclip.The adverse events were a direct result of the patient¿s dialysis venous line becoming unsecure and detaching from the catheter connection leading to the blood loss, hypovolemia, cardiopulmonary arrest and death.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

Information in the complaint file was reviewed by a pots market surveillance clinician.On 12/20/2017, a copy of a voluntary medwatch was received from a hemodialysis (hd) clinic that was previously submitted to the fda for this (b)(6) year old female end stage renal disease (esrd) patient on in-center hd for renal replacement therapy (rrt) to make notification that the patient expired during hd treatment.On (b)(6) 2017, approximately 2 ¼ hours into a scheduled 3 hour hd treatment, the patient was found unresponsive.The venous bloodline was noted to be disconnected from the tunneled jugular central venous catheter (not a fresenius product) with the hemaclip still in place.The patient was last checked 10 minutes prior to the patient being found unresponsive with a blood pressure 141/54 and pulse 98.The venous bloodline and central venous catheter line were then clamped and the blood pump stopped.The patient was placed on her left side, oxygen was applied and 911 was called.The automated external defibrillator (aed) was applied and cardiopulmonary resuscitation (cpr) was initiated.A total of 400ml normal saline was infused (unknown intravenous (iv) site) and two shocks were administered via aed (unknown rhythm).It is unknown what additional resuscitative efforts were performed.The patient was transported to the hospital via emergency medical services (ems) where she later expired.The problem codes listed on the medwatch are cardiopulmonary arrest, blood loss and hypovolemia.Additional information was obtained during a follow up phone call on (b)(6) 2018 with the hd center clinic manager.Per the manager, the patient¿s access site was not covered and the staff did not manipulate the bloodlines.It is unknown how the bloodline became detached, but the manager states that there is a ¿possibility the patient may have manipulated and disconnected the bloodlines¿.The machine did alarm once the patient became unresponsive.The patient¿s estimated blood loss is 500-1000ml, but difficult to determine as saline was administered.There was no reported malfunction or defect with the bloodline or hemaclip and the machine was pulled from service and put through several tests with no issues found and put back into service.It was unknown what make of catheter was being utilized.No additional information was available at this time.

• Brand Name: COMBISET ACCESS FLOW REVERSE CON TWISTER
• 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.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7188249
• MDR Text Key: 97267366
• Report Number: 8030665-2018-00078
• Device Sequence Number: 1
• Product Code: KOC
• UDI-Device Identifier: 00840861100316
• UDI-Public: 00840861100316
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2794-0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/02/2018
• 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
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 40