MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number UNKNOWN- FMC BLOODLINE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiopulmonary Arrest (1765); Hemorrhage/Bleeding (1888); Hypovolemia (2243); Loss of consciousness (2418); Blood Loss (2597)

Event Date 09/21/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A user facility clinical administrator reported that approximately 1 hour and 30 minutes into the patient¿s scheduled 3.5 hour hemodialysis (hd) treatment, the patient became unresponsive.The patient¿s blood pressure was noted to be a systolic of 90 and the patient was difficult to arouse.At this point in time, the vital signs were taken and noted to be blood pressure 118/62 and pulse was 87.There was blood noted underneath the patient¿s chair.The blood pump was stopped and the patient¿s access was assessed.The patient¿s arm was noted to have dropped in the chair, causing tension in the venous line.The venous fistula needle was noted to be dislodged.Pressure was applied to the venous site and blood was returned to the patient with normal saline administered via the arterial fistula needled.Oxygen was provided to the patient via nasal cannula and 911 called.The patient did not arouse with painful stimuli and the patient appeared to have agonal breaths with no pulse.Cardiopulmonary resuscitation (cpr) was initiated for one round before the patient opened their eyes and mumbled to the staff.A palpable pulse was present and apical heart sounds auscultated.Approximately 800 ml of normal saline was administered to the patient and hemostasis achieved on the venous cannulation site.The patient was transported to the emergency room (er) via emergency medical services (ems).The patient was admitted to the hospital and transfused with 2 units of packed red blood cells.Upon inspection of the venous avf needle, it was noted that the tape and gauze dressing were still intact on the fistula needle.Upon follow up, the clinical administrator reported that the patient was admitted to the hospital on (b)(6) 2018 following which, the patient became hemodynamically and clinically stable, and was discharged from the hospital on (b)(6) 2018.The clinical administrator stated that the cause of the event was the fistula needle and the tape.The clinical administrator confirmed that there was no allegation of product deficiency or malfunction against any fresenius device(s) or product(s) related to the reported event.

Manufacturer Narrative

The sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the facility for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius 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.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.

Manufacturer Narrative

Clinical investigation in h10 clinical investigation: it was reported that at 12:35 pm, approximately 1 hour and 30 minutes into treatment, the patient had a systolic blood pressure of 90 and was difficult to arouse.Blood (unknown amount) was observed under the patient¿s chair and the patient¿s venous fistula needle (jms wing eater needle; not a fresenius product) was completely dislodged from the patient¿s dialysis access with the gauze and tape (3m) still fastened to the needle.Per the report, the patient¿s arm dropped in the dialysis chair which allegedly caused tension on the venous fistula needle.It is unknown if the patient moved their arm or if the arm dropped due to a change consciousness.It is unknown if the 2008t machine alarmed in any way.The blood pump on the 2008t machine was stopped (unknown if performed manually or due to a machine alarm) and pressure applied to the venous site.The patient was reinfused with blood in the extracorporeal circuit with an 800 ml of saline via the arterial fistula needle and placed on oxygen (unknown amount) via nasal cannula.However, the patient remained unresponsive and presented with agonal breathing (unknown duration) and cardiopulmonary resuscitation (cpr) efforts were initiated.Based on the available information, there is no documentation or evidence that indicates a fresenius device(s)/product(s) malfunction or product deficiency caused the blood loss and change in level of consciousness during their treatment.The patient¿s blood loss was related to the patient¿s fistula needle becoming dislodged which was most likely related to tension upon the venous needle due to movement of the patient¿s arm.Additionally, the medwatch filed on (b)(6) 2018, implicated the jms wing eater fistula needle as the suspect device in the event; there were no reported allegations against any fresenius device(s).Venous needle dislodgement is a known and potentially serious complication of hd therapy.

Event Description

A user facility clinical administrator reported that approximately 1 hour and 30 minutes into the patient¿s scheduled 3.5 hour hemodialysis (hd) treatment, the patient became unresponsive.The patient¿s blood pressure was noted to be a systolic of 90 and the patient was difficult to arouse.At this point in time, the vital signs were taken and noted to be blood pressure 118/62 and pulse was 87.There was blood noted underneath the patient¿s chair.The blood pump was stopped and the patient¿s access was assessed.The patient¿s arm was noted to have dropped in the chair, causing tension in the venous line.The venous fistula needle was noted to be dislodged.Pressure was applied to the venous site and blood was returned to the patient with normal saline administered via the arterial fistula needled.Oxygen was provided to the patient via nasal cannula and 911 called.The patient did not arouse with painful stimuli and the patient appeared to have agonal breaths with no pulse.Cardiopulmonary resuscitation (cpr) was initiated for one round before the patient opened their eyes and mumbled to the staff.A palpable pulse was present and apical heart sounds auscultated.Approximately 800 ml of normal saline was administered to the patient and hemostasis achieved on the venous cannulation site.The patient was transported to the emergency room (er) via emergency medical services (ems).The patient was admitted to the hospital and transfused with 2 units of packed red blood cells.Upon inspection of the venous avf needle, it was noted that the tape and gauze dressing were still intact on the fistula needle.Upon follow up, the clinical administrator reported that the patient was admitted to the hospital on (b)(6) 2018 following which, the patient became hemodynamically and clinically stable, and was discharged from the hospital on (b)(6) 2018.The clinical administrator stated that the cause of the event was the fistula needle and the tape.A medwatch was submitted to the fda on the needle and the tape under the uf/importer report number (b)(4).The clinical administrator confirmed that there was no allegation of product deficiency or malfunction against any fresenius device(s) or product(s) related to the reported event.

Manufacturer Narrative

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

• Brand Name: FMC 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
• MDR Report Key: 8013478
• MDR Text Key: 125274949
• Report Number: 8030665-2018-01705
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018,11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- FMC BLOODLINE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2018
• Distributor Facility Aware Date: 09/21/2018
• Device Age: MO
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3M PAPER TAPE; DEXTROSE (100); FRESENIUS 160NRE DIALYZER; FRESENIUS 2008T MACHINE; GRANUFLO 2K; JMS FISTULA WINGEATER 15G; NATURALYTE 4000 BICARBONATE; NORMAL SALINE (1000 ML); 3M PAPER TAPE; DEXTROSE (100); FRESENIUS 160NRE DIALYZER; FRESENIUS 2008T MACHINE; GRANUFLO 2K; JMS FISTULA WINGEATER 15G; NATURALYTE 4000 BICARBONATE; NORMAL SALINE (1000 ML)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 52