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 04/11/2018

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 reported that the connection between the needle the arterial line of the combiset was not attached properly during the patient¿s hemodialysis (hd) treatment due to a defective arterial line connector, allowing air into the line and the blood to clot.The patient¿s treatment was discontinued and blood unable to be returned.The patients estimated blood loss (ebl) was 300 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was set up with new supplies and treatment completed successfully on the same machine.The needle being utilized was a 15 gauge needle, however, further information regarding the needle was not provided.The combiset was discarded and is not available to be returned to the manufacturer for physical evaluation.Additional patient and treatment information was not provided.

Manufacturer Narrative

Plant investigation: 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
• 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: 7490257
• MDR Text Key: 107476244
• Report Number: 8030665-2018-00648
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 17SR01187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER