MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K2 OLC WITH HEPARIN PUMP

Device Problems Misassembled (1398); Calibration Problem (2890); Connection Problem (2900)

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

Event Date 02/18/2014

Event Type  Injury  

Event Description

A biotechnician reported a pt felt sick and needed to be removed from the hemodialysis machine.The diagnostic screen showed 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.

Manufacturer Narrative

Based on the limited information available it is unk the outcome of the pt.Due to the lack of information, this mdr is being submitted as a serious injury.A supplemental report will be submitted upon completion of the physician's assessment of the reported information and the plant's investigation.

• Brand Name: 2008K2 OLC WITH HEPARIN PUMP
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICLA CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3717155
• MDR Text Key: 4265136
• Report Number: 2937457-2014-00425
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2014

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: 02/19/2014
• Initial Date FDA Received: 03/20/2014
• 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
• Treatment: SALINE; ACIDS; BICARBONATE; BLOOD LINES
• Patient Outcome(s): Other