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

Catalog Number 03-2722-9

Device Problem Fluid/Blood Leak (1250)

Patient Problems Headache (1880); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Blood Loss (2597)

Event Date 01/08/2019

Event Type  Injury  

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 custom combi set and the patient¿s adverse event(s) of headache, lightheadedness, blood loss and hypotension warranting observation in the er.The cause of the event(s) was a direct result of the patient¿s venous bloodline separating from the venous fistula needle (not a fresenius product).The cause of the disconnection is unknown; therefore, causality cannot be determined.Catheter/bloodline separation is uncommon; however, these event(s) can result in serious injury, significant blood loss and even death.Access lines should always remain visible to enable the detection of possible blood leaks.Based on the information available, the custom combi set cannot be disassociated from the event.While there is no documentation of any defect(s) at the connection site, samples were not retained following the event(s) nor was the connection visible for inspection during treatment.Therefore, no manufacturer investigation/evaluation can be made of the suspect product(s).Should additional information become available, the clinical investigation will be amended appropriately.

Event Description

It was reported that a hemodialysis (hd) patient experienced a disconnection between the fistula needle and bloodlines during their treatment, resulting in blood loss, lightheadedness, and hypotension.The patient arrived at the user facility for scheduled hd treatment alert and oriented.The patient¿s pre-dialysis vital signs were as follows: blood pressure 184/107, pulse 77, respiration 18, temperature 97.5.Hd treatment was initiated at 5:11am.At 6:55am, the patient stated that they had a headache and was lightheaded.The patient requested acetaminophen; their blood pressure was 66/38 and pulse was 69.The fresenius 2008t hd machine alarmed.The patient¿s fistula was covered with a blanket at this time and when the blanket was removed, it was noted that the venous blood line was disconnected from the venous fistula needle (not a fresenius product) line.The patient¿s estimated blood loss was 600-800ml; blood was noted on the floor, blanket, pillow, and the patient¿s shirt.Blood from the extracorporeal circuit was returned to the patient.Oxygen and 1000ml normal saline was administered, and emergency medical services (ems) was called.At 7:00am, the patient¿s blood pressure was 73/35 and pulse was 69.The patient stated that they felt better.At 7:09am, the patient¿s blood pressure was 121/64 and pulse was 64.Ems arrived at 7:10am and transported the patient to the hospital, where they were observed for several hours and then discharged home.The patient returned to their next scheduled dialysis treatment on (b)(6) 2019.Upon follow up, the clinical manager reported that the patient had to be reminded multiple times during treatment to refrain from moving their arm, although this cannot be confirmed as the root cause of the disconnection.The clinical manager confirmed that there were no loose connections, damage, or defects noted with any of the equipment or products involved in the events.It was confirmed that there were no changes in pressure noted that could have contributed to the reported event.It was confirmed that although acetaminophen was requested by the patient during treatment, the medication was not provided by the nurse.The patient was not admitted to the hospital, but was observed in the emergency room (er) with a heart rate monitor and oxygen administration.As a result of the event, the patient's erythropoiesis-stimulating agent was adjusted per the physician¿s orders.The patient's discharge summary was requested, but was not furnished.The manufacturers of the concomitant products have been notified of the reported event.

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review 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.

• Brand Name: CUSTOM COMBI SET
• 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: 8277393
• MDR Text Key: 134086573
• Report Number: 8030665-2019-00186
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• 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
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 18LR01301
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 49