MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERIC FESENIUS COMBISET 2008; NONE

Catalog Number 03-2722-9

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 07/20/2015

Event Type  Injury  

Manufacturer Narrative

Investigations findings to date indicated the reported malfunction occurred during dialysis treatment.It was reported the patient did lose 1 liter of blood: however did not require a transfusion and suffered no lasting ill effects.The investigation is pending a supplemental mdr will be filed at the completion of the investigation.

Event Description

A user facility reported at 10:21 am the patient's regular 3 1/2 hour hemodialysis treatment was initiated.At 1:17 pm it was discovered the venous needle had been pulled out by the patient.The needle was found located between the patient's body and arm.The normal venous limit alarm was set properly; however, the alarm did not sound to notify staff of the potential problem.Patient was sent to the hospital and was alert with stable vital signs.Blood pressure: 151/62, heart rate: 83 regular, temperature: 98.0.Staff on duty estimated 1 liter of blood loss.Patient did not require a blood transfusion at the hospital.The patient was discharged from the hospital on (b)(6) 2015.Per the clinical manager, the needle got pulled out from the patient's arm and the unit's alarm was not set high enough to hear.The unit was still operating; during post placement inspection, nothing was found wrong with the unit.The patient was given ethergen an esa to up her hemoglobin count and is getting better.The patient continues therapy without issue.There was nothing wrong with the bloodline.Functional testing of the dialysis machine post adverse event form was completed according to policy.The only issue found was the alarm volume (although audible) was not turned up all the way.No issues were found with the unit.

Manufacturer Narrative

Since the complaint sample was not available for evaluation, no analysis was performed, the complaint is deemed as "not confirmed" due to the fact that the incident was caused by the end user.An investigation of the lots delivered to the customer for the product in the three months prior to the event were reviewed and a lot number was not able to be determined investigation findings indicate that this incident was attributed to user error.An investigation of the product manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process, in addition, the batch record review confirmed the labeling, material and process controls were within specification.

• Brand Name: FESENIUS COMBISET 2008
• Type of Device: NONE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERIC; reynosa, tamaulipas ; MX
• Manufacturer (Section G): REYNOSA MANUFACTURING PLANT; brecha e99 sur parque; industrial reynos, bldg 11 cd; reynosa, tamaulipas 88790 ; MX 88790
• Manufacturer Contact: tanya taft, rn, cnor ; 8006621237
• MDR Report Key: 5041761
• MDR Text Key: 24627788
• Report Number: 8030665-2015-00385
• 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: Followup,Followup
• Report Date: 07/31/2015

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: Not provided
• Initial Date FDA Received: 08/27/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/18/2015; 10/06/2015
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 89 YR
• Patient Weight: 61