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

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A biomedical technician (biomed) at the user facility reported that a patient experienced blood loss while undergoing hemodialysis (hd) treatment.The following details were provided.The 2008t hd machine experienced an air detector and blood alarm.The blood pump rotor pins were backing out and punctured the bloodlines.The patient¿s blood was not returned.The estimated blood loss (ebl) was approximately 300 cubic centimeters (cc).There was no patient adverse effects and no medical intervention required as a result of this event.The patient¿s post treatment condition was fine.The biomed replaced the blood pump rotors to resolve the issue.Functional testing performed by the biomed confirmed the system was operating properly.The unit has been returned to service at the user facility without a recurrence of the event as reported.There was no allegation against the combi set bloodlines.The bloodline product was not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.The 2008t hd machine was not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

The reported complaint is not confirmed as the complaint device was not available for manufacturer evaluation, and the lot number of the suspect device was not provided.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A lot history review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.No information was found and no lots were identified during this review, which sought to identify the lot numbers for all bloodline tubing sets shipped to this account within the selected time frame.As the lot number was not identified by the user facility and since no lot information was identified during the ship history, a manufacturing review was not able to be performed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• 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: 6794793
• MDR Text Key: 82724966
• Report Number: 8030665-2017-00577
• 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: consumer,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/15/2017
• 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: 2008T HD MACHINE