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 Syncope (1610); Respiratory Distress (2045)

Event Date 10/27/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 11/27/2018, post market surveillance (pms) received a medwatch form - 3500a (submitted 11/07/2018) reporting this (b)(6) -year-old male patient with end stage renal disease (esrd) on hemodialysis (hd) thrice weekly for renal replacement therapy (rrt) for approximately 2 years, was found unconscious during hd therapy on (b)(6) 2018.The patient¿s past medical history includes hypertension (htn), diabetes mellitus (dm) type ii, chronic obstructive pulmonary disease (copd), congestive heart failure (chf).The medwatch form revealed the patient¿s venous fistula needle (not a fresenius product) dislodged, and the patient sustained blood loss of approximately 300 ml.Resuscitative measures were initiated at the user facility, and the patient was transferred to the hospital.On (b)(6) 2018, 45 minutes into a 4-hour hd treatment the 2008t hd machine¿s arterial alarm sounded, and the patient was found unresponsive and breathing erratically.The patient¿s venous fistula needle was found dislodged (tape remained connected to needle), and approximately 300ml of blood was noted on the floor.Vital signs provided indicated a blood pressure (bp) = 112/60 and a heart rate (hr) = 60 around the time of the event.The patient was placed in trendelenburg position, 10 liters of oxygen was applied via nasal canula and the patient was given 2000ml of normal saline (ns) through the arterial fistula needle.Emergency medical services was contacted, and the patient was transported to the hospital.The patient was drowsy but responding at the time of discharge from the outpatient dialysis clinic.The patient reportedly received 1 unit of packed red blood cells in the emergency room (er) and was discharged home.The patient returned for their next scheduled hd treatment on (b)(6) 2018.During follow-up on (b)(6) 2018, the patient¿s hdrn stated there was no complaint being made specifically concerning the bloodlines.The hdrn reported the dislodgement occurred due to the patient¿s movement(s) or by getting ¿caught on something.¿ additional information was requested, however the hdrn declined providing further specifics.

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 patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius combiset 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.

• 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: 8168610
• MDR Text Key: 130464345
• Report Number: 8030665-2018-02026
• 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
• Report Date: 12/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• 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
• Device Age: MO
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS DIALYZER; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS DIALYZER; FRESENIUS HEMODIALYSIS MACHINE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 94