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 Cardiac Arrest (1762); Blood Loss (2597)

Event Date 04/18/2020

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: the file was assessed to determined whether a clinical investigation is warranted.On (b)(6) 2020 the patient was in treatment utilizing the fresenius 2008t machine when he pulled out the needle.The patient was bleeding and went into cardiac arrest.The patient was transported to the hospital where he was admitted and remains today.The event was unrelated to any fresenius product(s).There were no issues with the treatment prior to the patient pulling the needle.The patient has a history of pulling lines, clamps, and needles due to confusion issues.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.Additionally, there is no allegation of a malfunction against any fresenius product(s).Therefore, the completion of a clinical investigation is not warranted at this time.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-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.

Event Description

It was reported by a hospital registered nurse (rn) that a fresenius patient pulled out his catheter (non-fmc manufacturer) and went into cardiac arrest.Upon follow up with the user facility it was reported that the patient s in in-center hemodialysis (hd) patient.The patient hdrn reported that the patient does not have a catheter and utilizes a fistula.On (b)(6) 2020 the patient was in treatment utilizing the fresenius 2008t machine when he pulled out the needle.The patient was bleeding and went into cardiac arrest.The patient was transported to the hospital where he was admitted and remains today.The event was unrelated to any fresenius product(s).There were no issues with the treatment prior to the patient pulling the needle.The patient has a history of pulling lines, clamps, and needles due to confusion issues.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.Additionally, there is no allegation of a malfunction against any fresenius product(s).

• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 1100 e, military hwy, suite c; pharr TX 78577
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 10027339
• MDR Text Key: 190204124
• Report Number: 8030665-2020-00591
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR