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 Fluid/Blood Leak (1250)

Patient Problems Syncope (1610); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 04/11/2019

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 clinic manager reported that a hemo clip became loose about an hour into the patient¿s hemodialysis (hd) treatment and the patient lost blood.The lumen on the patient¿s dialysis catheter (not a fresenius product) had become loose from the combi-set blood line, which was the visual source of blood loss.The machine, a fresenius 2008t machine, did not alarm.There was no defect or damage seen on the hemo-clip or combi set.The patient¿s estimated blood loss (ebl) was approximately 300 ml.Subsequently, the patients bp was noted to be 83/45, with hr 105, (sinus tachycardia).The patient was treated by clamping the source of blood loss, a blood sample was sent for stat hemoglobin level, and 1 liter of 0.9% sodium chloride was infused.Reportedly, the patient then continued and completed treatment without further complication.Stat hemoglobin result returned a value of 8.1 vs.The pre-treatment value noted to be 10.4.At completion of treatment, the patient reported onset of chest pain rated at 2:10 (no prior history of chest pain or ischemic events).Emergency medical services (ems) was activated and the patient was transported to the emergency department (ed).Reportedly, upon arrival an electrocardiogram (ecg) which showed concern for possible st-segment elevation (unknown which leads).The patient was transported to another facility for cardiac catheterization to rule out ischemic event due to increased cardiac demand.Per the clinic manager, the cardiac catheterization was negative for an ischemic event.The patient¿s current status is reported as doing well, discharged from hospital, and has resumed scheduled hd treatment.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Patient codes clinical review: a temporal association exists between the patient¿s blood loss with subsequent hypotension, syncope, and chest pain during this hd treatment and the fresenius hemo-clip, fresenius bloodlines.However, there is no documentation or reports of any visible defects with the fresenius hemo-clip or the fresenius blood lines in use at the time of the event.The adverse event was a direct result of the patient¿s dialysis venous line becoming unsecured and partially detaching from the catheter connection leading to blood loss, syncope, hypotension and chest pain.Based on the available information, it is unknown what may have occurred to cause the catheter and the venous bloodline to become unsecured during the hd treatment.Additionally, it is unclear why the reported blood loss was not observed prior to the patient losing consciousness as it was recorded on the treatment record that safety check were being performed.

Event Description

Review of the patient¿s treatment record shows the hd registered nurse was alerted the patient had become unresponsive (syncope);.It was observed that the venous lumen of the dialysis catheter and the venous bloodline had become disconnected with the hemo-clip holding both ends together in place which resulted in an approximate blood loss of 300 ml.The patient was treated by clamping the source of blood loss, the connection was secured, and a bolus of 1000 ml¿s of 0.9% sodium chloride was given.Following volume replacement, the patient became responsive and bp was recorded as 139/81 and hr 100.Additionally, there were reports the patient indicated feeling dizzy, lightheaded and nauseous; however, per nursing documentation this had resolved.Treatment resumed as ordered reportedly with the same machine and new supplies.Subsequently, patient¿s blood pressure was recorded as 83/49 and an additional 300 ml¿s of 0.9% sodium chloride was given.Subsequently, the patient¿s blood pressure was 95/54, hr 104, and the patient reported experiencing chest and jaw pain.Per documentation, the patient then received an additional 500 ml¿s of fluid replacement and the treatment was completed with and ending bp of 90/45 and hr 107.Subsequently, after treatment was completed (exact time unknown), the patent reported feeling dizzy with a recorded blood pressure of 83/49 while sitting in the chair.The patient was given 500 ml¿s 0.9% sodium chloride and the patient¿s blood pressure increased to 97/56.However, the patient reported 2:10 mid-sternal chest pain with intermittent jaw pain.As a result, the patient was transported by emergency medical services to a local emergency department for further clinical evaluation.Per hospital discharge summary, the patient was admitted for acute blood-loss anemia which caused the syncopal event.There was also concern for myocardial infarction (mi) due to possible st-elevation noted on electrocardiogram (ecg); however, this was ruled out by cardiac catherization.The patient was transfused with one unit of packed red blood cells (prbc) with a subsequent increase in hgb to 8.4.Additional details surrounding the patient¿s hospitalization are unknown.The patient was discharged to the nursing home facility, and the patient¿s regular hd treatments have resumed without further reported issues.

Manufacturer Narrative

Plant investigation: 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-conformance's 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: 8590825
• MDR Text Key: 144428933
• Report Number: 8030665-2019-00696
• 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
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- FMC BLOODLINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER; FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 96