MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA PRIMING SET FOR ARTERIAL BLOODLINES; KOC

Catalog Number 04-9006-5

Device Problem Connection Problem (2900)

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

Event Date 04/29/2015

Event Type  malfunction  

Event Description

A user facility reported that they experienced air in the line when connecting the tubing set and iv set because the connection was not sealing properly.No air reached the patient.Treatment was not missed as a result of this incident.The sample was not available for evaluation.

Manufacturer Narrative

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

• Brand Name: PRIMING SET FOR ARTERIAL BLOODLINES
• Type of Device: KOC
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque ind. reynosa sur,; brecha e-99 apartado postal #326; cd, reynosa, tamps ; MX
• Manufacturer Contact: tanya taft,rn, cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999105
• MDR Report Key: 4752193
• MDR Text Key: 16861931
• Report Number: 8030665-2015-00226
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Catalogue Number: 04-9006-5
• Device Lot Number: 13PRO01039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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: 60 YR
• Patient Weight: 57