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 Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 03/10/2018

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 reported via medwatch (mw5075925) that the blood pump tubing developed a leak from scraping the tubing wall from a loose tubing guide on the pump rotor during a patient's hemodialysis (hd) treatment.Per the report, a serious injury occurred requiring hospitalization.Additional information needed for follow up was not provided and is unable to be obtained.

Manufacturer Narrative

Additional information: clinical investigation clinical investigation: a temporal relationship exists between the hemodialysis (hd) therapy utilizing an unknown fresenius 2008k hemodialysis machine, an unknown fresenius bloodline, and the patient¿s adverse event of probable blood loss which warranted hospitalization.It is known that bent or lose tubing guides (on the 2008k machine) can damage blood lines.Therefore, a probable causal relationship exists between the unknown fresenius 2008k hemodialysis machine, unknown fresenius bloodline and the patient¿s likely blood loss and hospitalization event(s).Plant investigation: the sample was not returned to the manufacturer and the lot number of the product is unknown.No device history record (dhr) review was performed since the lot number is unknown and no information was available.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.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 7449876
• MDR Text Key: 106136839
• Report Number: 8030665-2018-00583
• 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: other
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- FMC BLOODLINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization