MAUDE Adverse Event Report: REYNOSA MANUFACTURING CUSTOM COMBI SET 2008

Catalog Number 03-2722-9

Device Problems Air Leak (1008); Loose or Intermittent Connection (1371); Use of Device Problem (1670)

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

Event Date 04/02/2014

Event Type  malfunction  

Event Description

The user facility reported that the bloodline was improperly secured, allowing air into the line during treatment.According to the certified clinical hemodialysis technician, there was a loose connection where the bloodline twists onto the fistula needle tubing.She said there was nothing wrong with the device; she had mde the connection herself and it seemed tight, but it had apparently been twisted at a slight angle so that it was cross-threaded, which allowed air to be sucked in during use.The air was captured within the drip chamber and never made it into the pt.She used a 10 cc syringe to try and remove the air from the drip chamber when the plunger of the syringe came out of the barrel of the syringe, causing blood to spurt out of the syringe.Treatment was resumed and completed with no complications to the pt, who lost 10 cc blood and was fine.

Manufacturer Narrative

The device was disposed of and is not available for physical evaluation.A plant investigation is in progress and a supplemental report will be submitted upon completion.

• Brand Name: CUSTOM COMBI SET 2008
• Manufacturer (Section D): REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331; parque industrial reynosa; reynosa, tamaulipas, CP 8 8780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st; waltham, MA 02451 ; 7816999751
• MDR Report Key: 3963695
• MDR Text Key: 16180200
• Report Number: 8030665-2014-00341
• 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 Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2014
• 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
• Treatment: FRESENIUS 2008K HEMODIALYSIS MACHINE