MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE CONCORD PLANT 2008K2 OLC WITH HEPARIN PUMP

Device Problem Misassembled (1398)

Patient Problem Electrolyte Imbalance (2196)

Event Date 02/14/2014

Event Type  Injury  

Event Description

A user facility reported a patient experienced post-surgical complications which required hemodialysis.On (b)(6) 2014 during hemodialysis treatment, technical difficulties were experienced.A half hour into treatment the patient started to feel sick.The patient was removed from the machine and diagnostics tests were performed.The diagnostics screen read the pre conductivity cell was 14.4 but the post conductivity cell read 19.8.The conductivity meter was then plugged into the machine and read 19.8 matching the post conductivity cell.Trouble shooting measures were taken and it was found the acid wand and bicarb wand hoses were swapped.The acid wand was feeding the bicarb pump and the bicarb wand was feeding the acid pump.As a result of the mix up the patient experienced acute hyperkalemia, hypernatremia, hypercalcemia and hyperchloremia with associated symptoms.A repeat run of dialysis was performed the same day which improved the patient's electrolytes.His last dialysis was on (b)(6), his catheter was removed.The patient continues oral lasix as needed to help with volume status and electrolyte balance.

Manufacturer Narrative

A supplemental report will be submitted upon final review of medical records by post market clinical physician and completion of the plant's investigation.

• Brand Name: 2008K2 OLC WITH HEPARIN PUMP
• Manufacturer (Section D): FRESENIUS MEDICAL CARE CONCORD PLANT; 4040 nelson ave; concord CA 94520
• Manufacturer (Section G): FRESENIUS MEDICAL CARE CONCORD PLANT; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3709109
• MDR Text Key: 4338818
• Report Number: 2937457-2014-00419
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2014

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2014
• Initial Date FDA Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR