MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET W/SPLIT SEPTUM; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number 03-2630-6

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

Patient Problems Syncope (1610); Low Blood Pressure/ Hypotension (1914); Hypovolemia (2243); Blood Loss (2597)

Event Date 01/18/2020

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system, custom combi set and the adverse events of needle dislodgement, blood loss and hypovolemia requiring hospitalization and the infusion of prbcs.Causality for the events is attributed to the patient¿s venous fistula needle (not a fresenius product) becoming dislodged during hd therapy; however, it is unknown how the needle became dislodged.Although access needle dislodgement is uncommon, these events can result in serious injury, significant blood loss and even death.Additionally, venous needle dislodgements are known to occur without triggering a venous pressure alarm due to the back pressure created by the narrow-bore needles or partial dislodgement.Based on the information available, the 2008t hemodialysis system can be disassociated from the events, as there is no evidence or indication a 2008t hemodialysis system malfunction caused or contributed to the serious adverse events.The needle dislodgement occurred at the point where the needle contacts the skin.Additionally, there is no evidence the 2008t hemodialysis system failed to perform as expected in relation to the events.Machine alarms may not occur in every blood loss situation.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a patient with renal failure on hemodialysis (hd) for renal replacement therapy (rrt) felt unwell during their hd treatment on (b)(6) 2020.The patient was reportedly in the acute dialysis unit at a hospital, transported from the rehabilitation department.Upon evaluation, it was discovered that the patient¿s venous fistula needle dislodged, and the patient sustained blood loss of approximately 1 l.The needle tip was sitting against the patient¿s skin.The machine, a fresenius 2008t hemodialysis system, did not alarm.The needle was connected to a fresenius custom combi set, which was reportedly discarded after use.The patient was given 1 l of normal saline and was admitted for the transfusion of 2 units of packed red blood cells (prbcs).The patient was hospitalized overnight and discharged on (b)(6) 2020.Subsequent attempts to obtain additional information have thus far proven unsuccessful.

Manufacturer Narrative

Additional information was received and inadvertently omitted from follow-up #1.The following patient codes were added as additional information in follow-up #1: c3128-hypotension and c35053-syncope.The codes for hypovolemia and blood loss were inadvertently removed, but they were still applicable.

Event Description

It was reported that a patient with renal failure on hemodialysis (hd) for renal replacement therapy (rrt) felt unwell during their hd treatment on (b)(6) 2020.The patient was reportedly in the acute dialysis unit at a hospital, transported from the rehabilitation department.Upon evaluation, it was discovered that the patient¿s venous fistula needle dislodged, and the patient sustained blood loss of approximately 1 l.The needle tip was sitting against the patient¿s skin.The machine, a fresenius 2008t hemodialysis system, did not alarm.The needle was connected to a fresenius custom combi set, which was reportedly discarded after use.The patient was given 1 l of normal saline and was admitted for the transfusion of 2 units of packed red blood cells (prbcs).The patient was hospitalized overnight and discharged on (b)(6) 2020.Initial attempts to obtain additional information were unsuccessful.Additional documentation was received and revealed the patient was experiencing upper extremity weakness, numbness and tingling, and was hospitalized on 16/dec/2019 for the surgical repair of their cervical stenosis.On 17/dec/2019, the patient successfully underwent an anterior cervical discectomy (acdf) and was transferred on 21/dec/2019 to a rehabilitation hospital for physical/occupational therapy, pain control and wound care following surgery.Follow-up details confirmed the patient was transported from the rehabilitation department, to the hospital¿s acute dialysis service for hd therapy on 18/jan/2020.The patient¿s hd treatment was ¿uneventful¿ (timeline not provided) until the patient complained of ¿not feeling good¿ (shortness of breath and syncope).Upon evaluation by a clinician, it was discovered the patient¿s venous access needle was dislodged, and the needle tip was sitting against the patient's skin.The patient¿s fistula needle was reportedly secured with 1-inch paper tape.The document states the 2008t hemodialysis system did not alarm, and the patient lost 1 l of blood.A complete blood count (cbc) was collected (results not provided) following the event, and the patient was given 1 l of intravenous (iv) normal saline to stabilize their blood pressure (value not provided) and syncope.The hd treatment was restarted following the dislodgement, and the patient was transfused with 2 units of packed red blood cells (prbcs).The transfusions and hd treatment were successfully completed, and the patient was sent back to the rehabilitation hospital in stable condition (initially reported patient was acutely hospitalized overnight).The cause of the needle dislodgement was attributed to the patient being ¿uncomfortable and constantly repositioning" themselves.

Manufacturer Narrative

Additional information: a1, a2, a3, b6, b7 plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A shipping history search was performed on combi set lots delivered to the customer for the three (3) month time frame which immediately preceded the event occurrence date.According to the search results, the reported catalog number was not delivered during the selected time frame.A follow up with the unit¿s nurse manager confirmed that the correct catalog number was provided to the manufacturer.As a lot number could not be determined, device history and manufacturing records could not be reviewed.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.Should additional relevant information become available, a supplemental report will be submitted.Clinical investigation: a temporal relationship exists between hd therapy utilizing the custom combi set and the adverse events of venous needle dislodgement, blood loss, hypovolemia, hypotension and syncope requiring the infusion of prbcs.Causality for the events is attributed to the patient¿s venous fistula needle (not a fresenius product) becoming dislodged during hd therapy.The patient¿s registered nurse reported the venous needle became dislodged due to the patient being uncomfortable and frequently shifting positions.Based on the information available, the custom combi set can be disassociated from the events.There is no objective evidence indicating a fresenius product(s) or device(s) deficiency or malfunction caused or contributed to the serious adverse events.The needle dislodgement occurred at the point where the needle contacts the skin.Additionally, there is no objective evidence the 2008t hemodialysis system alarm system failed to perform as expected in relation to the events.Machine alarms may not occur in every blood loss situation.

• Brand Name: CUSTOM COMBI SET W/SPLIT SEPTUM
• 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: 9696505
• MDR Text Key: 179259954
• Report Number: 8030665-2020-00187
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100248
• UDI-Public: 00840861100248
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 03-2630-6
• Device Catalogue Number: 03-2630-6
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR