MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE CUSTOM COMBI SET

Catalog Number 03-2722-9

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/21/2014

Event Type  Injury  

Event Description

A hemodialysis inpatient user facility has reported that during treatment, the pt experienced two blood leaks related to the crit-line blood chamber and the customer combi set.The estimated blood loss was approximately 110ml due to the two blood leaks approximately 100ml through the site of the arterial line/dialyzer connection and less than 10ml from the heparin line.The pt was reclined in her chair and her arterial blood was rinsed back.The venous blood was not rinsed back due to air in the tubing.A stat hemoglobin was drawn and the pt received 300ccs of normal saline.She was placed on oxygen at 3 liters.Her hemoglobin dropped to 8.7, then 7.6 from her previous treatment's hemoglobin of 9.7 on (b)(6) 2014.The pt was alert and talking and remained asymptomatic.There was no blood transfusion required.The heparin line was reported to be dysfunctional where the end cap would not screw on and began leaking after two hours of use.The heparin line was clamped, tied in a knot and the bleeding stopped.The pt's post-dialysis vital signs were: blood pressure: 143/64, pulse: 83 and regular, respirations: 18, and temperature: 97.6.Medical intervention involved oxygen, 300ml of normal saline, arterial line blood return, and trendelenburg position.The 2008t hemodialysis machine had passed all tests prior to use.

Manufacturer Narrative

Medical records concluding summary of findings as event related to fresenius product(s): based on the 19 pages of medical records information and a review of the documentation in the fresenius pilgrim system, it appears that on (b)(6) 2014, while receiving hemodialysis, the pt experienced two blood leaks related to the crit-line blood chamber and the customer combi set.This pt experienced a blood loss of approximately 110ml due to the two blood leaks.Medical intervention involved oxygen, 300ml of normal saline, arterial line blood return, and trendelenburg position.The 2008t hemodialysis machine passed all tests prior to use.The first blood leak of 100ml was not discovered by the clinic staff until 40 minutes after the event occurred.The second blood leak was allegedly due to a dysfunctional heparin line, where the end cap would not screw on and began leaking after two hours of use.It is undetermined if there is a reasonable suspected causal relationship between the products and the event.This event is being filed as an mdr reportable serious injury to comply with our regulatory commitment to report any serious injury while using a fresenius device if the device investigation has not been completed.

• Brand Name: CUSTOM COMBI SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; reynosa plant, reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331 parque industrial; reynosa, tamaulipas CP 8 8780; MX CP 88780
• Manufacturer Contact: dianne chin ; 920 winter street; waltham, MA 02451-1457 ; 7816999105
• MDR Report Key: 4085077
• MDR Text Key: 4857917
• Report Number: 8030665-2014-00651
• 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 Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2014
• Initial Date FDA Received: 08/19/2014
• 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
• Treatment: FRESENIUS 2008T HEMODIALYSIS MACHINE; FMC BLOODLINES; 180NRE OPTIFULX DIALYZER; ACIDS AND BICARBONATE
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 80