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 Hypovolemia (2243); Loss of consciousness (2418); Blood Loss (2597)

Event Date 12/27/2018

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hemodialysis (hd) therapy utilizing the fmc bloodline and the adverse event(s) of blood loss, hypovolemia and loss of consciousness requiring hospitalization and the infusion of packed red blood cells (prbc¿s).Causality for the event(s) is attributed to the patient¿s venous fistula needle (not a fresenius product) becoming dislodged during hd therapy.It is unknown how the needle became dislodged.Access dislodgement is uncommon, however these event(s) can result in serious injury, significant blood loss and even death, as hd machines may not always detect blood loss.Based on the information available, the fmc bloodline can be disassociated from the event as there is no evidence or indication the fmc bloodline caused or contributed to a serious adverse event.The needle dislodgement occurred at the point where the needle contacts the skin.Additionally, there is no allegation or evidence of a malfunction or of the fmc bloodline failing to perform as expected in relation to the event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A user facility reported that a patient¿s venous fistula needle became dislodged during the patient¿s hemodialysis (hd) treatment on (b)(6) 2018.The patient arrived to their scheduled treatment alert and oriented.Their pre-dialysis vital signs (vs) were obtained with a blood pressure (bp) of 152/77, pulse 73, respiratory rate (rr) 20, and temperature 97.6 fahrenheit (f).The patient¿s hd treatment was initiated at 13:21 and vs checked every 20 minutes.At 14:01, the patient¿s bp was recorded as 128/68 and pulse 75.Approximately 8 minutes later, the machine, a fresenius 2008t machine, alarmed and the patient was found unresponsive with the tip of the venous needle dislodged.The tape was reported to be still intact on the patient¿s skin and large amounts of blood were noted on the floor.The patient¿s estimated blood loss (ebl) was 300 ¿ 400 ml.The venous line of the fresenius combiset was clamped and pressure applied to the venous cannulation site.The blood was returned to the patient via the arterial needle and normal saline (800 ml) administered via the arterial needle as well.Oxygen was applied to the patient via mask at 3 liters per minute (lpm), aed pads placed on the chest, cardiopulmonary resuscitation (cpr) initiated, and 911 called.The patient began spontaneously breathing at 14:13 and vs upon discharge from the facility recorded as bp 156/99, pulse 102, rr 23, and temperature 97.8 f.The patient was transported to the hospital via emergency medical services (ems) and subsequently admitted.The patient was transfused with 3 units of packed red blood cells (prbcs) during their hospitalization and was discharged from the hospital on (b)(6) 2019.The patient was schedule to return to the clinic for hd treatments on (b)(6) 2019.Upon follow up, the patient¿s hd nurse confirmed that the fresenius combiset did not cause or contribute to the patient¿s needle dislodgement.The cause of the needle dislodgement remains unknown, however the hd nurse stated it was the first time they have ever witnessed a needle dislodgement where the tape remained intact on the needle.The discharge summary for the event remains unavailable.The patient has recovered from the event and continues to receive outpatient hd therapy.

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 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: 8293675
• MDR Text Key: 134625894
• Report Number: 8030665-2019-00235
• 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: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• 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: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3M DURAPORE TAPE; DEXTROSE (100); FRESENIUS 180NRE DIALYZER; FRESENIUS 2008T MACHINE; GRANUFLO 2K 2.5CA 1MG; JMS FISTULA WINGEATER 15X1B; NATURALYTE (4000) BICARBONATE; NORMAL SALINE (1000 ML); 3M DURAPORE TAPE; DEXTROSE (100); FRESENIUS 180NRE DIALYZER; FRESENIUS 2008T MACHINE; GRANUFLO 2K 2.5CA 1MG; JMS FISTULA WINGEATER 15X1B; NATURALYTE (4000) BICARBONATE; NORMAL SALINE (1000 ML)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 63