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

Catalog Number 03-2622-3

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/01/2018

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 nurse reported a blood leak that occurred 10 minutes after the beginning of the patient¿s hemodialysis (hd) treatment.The blood leak was visually observed in the bloodlines.The patient¿s estimated blood loss (ebl) was approximately 1ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient successfully completed treatment on the same machine with new supplies.The complaint device was discarded and is not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed, however photos were provided by the complainant.The photos received confirmed the alleged product malfunction as a separation was found between the heparin line and red t connector.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.

• Brand Name: 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: 8037860
• MDR Text Key: 126106963
• Report Number: 8030665-2018-01770
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100231
• UDI-Public: 00840861100231
• 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: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 18ER01059
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 4008S MACHINE; FRESENIUS DIALYZER; FRESENIUS 4008S MACHINE; FRESENIUS DIALYZER
• Patient Weight: 46