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 03-2722-9

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/31/2018

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 register nurse (rn) reported that a new patient in hemodialysis (hd) therapy was experiencing reactions (unknown signs/symptoms) upon initiation of dialysis treatment.Per follow up with the register nurse, the cause of patient reaction was unknown.The rn stated that the patient has since moved to an outpatient unit (location unknown) and reported that the patient is doing better.Additionally, the rn stated that before patient¿s treatment, both the dialyzer and the bloodlines are rinsed with saline solution (amount unknown).Additional information regarding patient¿s demographics, patient¿s outcome/status, product lot number, or how long the patient has been experiencing the reaction, and treatment records was requested.However, the rn stated that since the patient has since moved to another facility, that information might not be available.

Manufacturer Narrative

Clinical review: there is a possible causal association between use of the fresenius combiset bloodline and the pt¿s reaction (unspecified type; unknown signs and symptoms).The fresenius combiset blood line is gas sterilized with ethylene oxide.Although rare, ethylene oxide is known to cause allergic reactions during hemodialysis.The pt.Has since continued hd therapy (unknown products) without further reported issue.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported this patient (pt.) new to hemodialysis (hd) therapy experienced a reaction (unknown signs and symptoms) upon initiation of in-patient hd treatment using the fresenius combi-set bloodline.A registered nurse (rn) familiar with the event reported the fresenius bloodlines were rinsed with saline (unknown amount) prior to the pt¿s treatment, per physician order.Additional details surrounding the pt¿s hd treatment are unknown.It is unknown if the pt.Required any medical intervention because of the reaction.The exact cause for the pt¿s reaction was unknown.Per the rn, the pt.Has since continued hd therapy outpatient (unknown products) and is doing much better.

Manufacturer Narrative

The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.All companion samples have been sold and distributed.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

Event Description

".".

• 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
• 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: 7601889
• MDR Text Key: 111073564
• Report Number: 8030665-2018-00910
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: MO
• Date Manufacturer Received: 07/03/2018
• 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
• Patient Outcome(s): Required Intervention