MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2722-9

Device Problems Fluid/Blood Leak (1250); Misconnection (1399)

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

Event Date 02/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The parts have not yet been returned to the manufacturer for physical evaluation and the plant investigation is on-going.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A user facility reported a blood leak occurred during a patient's treatment.It was reported the connection was not fully secured to the dialyzer, resulting in minimal blood loss at the connection of the arterial line to the dialyzer port.The connector was re-tightened and treatment was continued.There was no damage or irregularities identified on the arterial connector of the combi set.The machine did not alarm.The estimated blood loss was less than 10ml.There were no adverse effects experienced by the patient.No medical intervention was required and the patient finished treatment on the same machine after the connection was re-tightened.The patient was dialyzing on a fresenius 2008t hemodialysis machine with a baxter brand dialyzer.The blood lines were retained and a failure analysis sample kit has been sent to the customer to return for investigation.

• Brand Name: CUSTOM COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; erika de reynosa; reynosa
• Manufacturer (Section G): REYNOSA; erika de reynosa; parque industrial reynosa; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5448357
• MDR Text Key: 39021660
• Report Number: 8030665-2016-00079
• Device Sequence Number: 1
• Product Code: FJK
• 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: Other
• Type of Report: Initial
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 15PR01268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2016
• Date Device Manufactured: 11/01/2015
• 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: 56