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

Catalog Number 03-2742-9

Device Problem Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: conclusion(s): a temporal relationship exists between hd therapy utilizing the custom combi set and the adverse event(s) of hypotension and blood loss requiring hospitalization and the infusion of prbcs.Causality for the event(s) is attributed to the patient¿s venous bloodline being improperly tightened to the venous fistula needle.Access dislodgement is uncommon; however, these event(s) can result in serious injury, significant blood loss and even death, as hd machines may not always detect blood loss.Based on the information available, the custom combi set can be disassociated from the event as there is no evidence or indication the custom combi set caused or contributed to a serious adverse event.

Event Description

A user facility clinical manager reported a blood leak between the fresenius combi set bloodlines and the patient¿s fistula needle.The blood leak was noticed approximately 3 hours into the patient¿s hemodialysis (hd) treatment.The clinical manager reported that the leak was due to a loose connection and suspects that it was not tightened properly during setup.The patient¿s treatment was discontinued, a 600ml saline bolus administered, and sent to the hospital for evaluation.The patient's estimated blood loss (ebl) was approximately 550ml.Per the clinical manager, the patient was admitted to the hospital on (b)(6) 2018 and discharged on (b)(6) 2018.Additional details regarding the patient¿s hospital visit were requested, however, were unknown.The patient has since continued hemodialysis treatment with no further issues or without reoccurrence of the reported event.Additional details regarding the reported event, including treatment records, were requested but not provided.The manufacturer of the patient's fistula needle "is jms was unknown".It was confirmed that the complaint device was discarded and is not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

As the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review 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.

• Brand Name: CUSTOM COMBI SET
• 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: 8134412
• MDR Text Key: 129384994
• Report Number: 8030665-2018-01965
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 18JR01228
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER; FRESENIUS GRANUFLO CONCENTRATE; FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER; FRESENIUS GRANUFLO CONCENTRATE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 102