MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CUSTOM COMBI SET

Catalog Number 03-2722-9

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

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

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

Plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

Event Description

A user facility reported during initiation of treatment, blood was seen leaking from underneath the arterial port.The nurse suspected a loose connection may have caused the leak.Blood was not returned to patient and the estimated blood loss was 200 cc's.There were no adverse effects to the patient.The blood flow rate was documented at 375 ml/min.The blood lines were replaced with a new set, and patient was able to successfully complete their treatment.

Manufacturer Narrative

Patient's weight was entered incorrectly.(b)(6).The device was not returned to the manufacturer for physical evaluation and field service was not requested, therefore, the failure mode cannot be confirmed.The facility biomedical technician confirmed he could not duplicate the issue.However, an investigation of the device 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: CUSTOM COMBI SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa manuacturing; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque ind. reynosa sur, brecha e-99; apartado postal #326; reynosa, tamps 88780 ; MX 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451 ; 7816999751
• MDR Report Key: 5070196
• MDR Text Key: 25697080
• Report Number: 8030665-2015-00410
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2018
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 15DRO1018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2015
• 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: 38 YR
• Patient Weight: 89