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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 06/02/2017

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¿s registered nurse reported that a patient experienced blood loss while undergoing hemodialysis (hd) therapy.The following details were provided.The patient placed a gauze over the needle site without tape, causing the needle to dislodge during treatment.The patient attempted to reposition the needle unsuccessfully.Treatment was terminated.The patient went to the emergency department for a suture to stop the bleeding.The estimated blood loss (ebl) was unknown.No malfunction of the machine was observed or identified, prior to, during, or following the hd therapy.The bloodline was not available to be returned to the manufacturer as it was discarded by the user facility.

Manufacturer Narrative

Correction: it has been confirmed that the bloodlines used at the time of this event were nxstage bloodlines (not a fresenius product).Therefore, no further follow-up will be expected. a search was performed of all fresenius bloodline products shipped to the facility for the three (3) month time frame which immediately preceded the event occurrence date and no lots were found to have been shipped.

• 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.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6834860
• MDR Text Key: 84248503
• Report Number: 8030665-2017-00630
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/10/2017
• 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
• Treatment: JMS FISTULA NEEDLE
• Patient Outcome(s): Required Intervention