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 Fluid/Blood Leak (1250)

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

Event Date 07/03/2017

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 user facility nurse reported that during a patient¿s hemodialysis (hd) treatment, approximately 1 ml (milliliters) of blood leaked from the venous port of the fresenius bloodline.Follow-up information with the clinic manager revealed that approximately five to ten minutes after the initiation of hd treatment, the patient care technician (pct) noticed a significant amount of air on the header of the dialyzer.The pct confirmed that all connections were secure and tight.It was then noticed that there was some blood coming out of the venous blood sample port.There was no machine alarm and no reported machine malfunction.The patient's estimated blood loss (ebl) was noted as being approximately 1ml.The treatment was immediately stopped and the patient was set-up with new supplies.No patient adverse effects or injuries were experienced and no medical intervention was required.The patient was able to complete treatment on the hd machine without any further interruptions or complications.The bloodline device was not available to be returned to the manufacturer as it was discarded.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A records review was performed on the reported lot.An investigation of the device history records (dhr) 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.In addition, the dhr review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.

• 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: 6727563
• MDR Text Key: 80513906
• Report Number: 8030665-2017-00458
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 17CR01418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2017
• 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 Age: 87 YR
• Patient Weight: 83