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); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A manufacturing 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.This review included the lot numbers for all fresenius bloodlines shipped to this account within the selected time frame.A records review was performed on all lots identified.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.All the applicable in-process and final inspection tests had acceptable results.The product lots involved met all specifications for release.A review of the batch production records did not reveal a probable cause for the customer complaint.There were no non-conformances identified that relate to the reported event, and all lots reviewed met release criteria.

Event Description

A user facility biomedical technician (biomed) reported that the patient experienced blood loss while undergoing hemodialysis (hd) treatment on a 2008t hd machine.The biomed reported that the blood pump tubing segment was pulled up into the blood pump, wrapped around the rotor and tore.The total estimated blood loss (ebl) was noted as being approximately one unit of blood.The hd treatment was discontinued approximately six minutes early.There was no blood observed on the blood pump tubing holder.Following the event the system was removed from service for evaluation.A fresenius regional equipment specialist (res) performed an on-site evaluation of the machine.The res inspected the rollers, tubing guides, and tubing retainer/release, which were intact and functioning properly.The res verified pumping flow and verified that the tubing set could be removed and replaced multiple times without any issues.The biomed informed the res that the tubing retainer/release was replaced prior to the res inspection.The unit is reportedly approved to be returned to service at the user facility.No parts are reported to be available to be returned to the manufacturer for evaluation.No further information has been made available at this time.

• 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: 6724697
• MDR Text Key: 80431756
• Report Number: 8030665-2017-00453
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 06/26/2017
• 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