MAUDE Adverse Event Report: REYNOSA MANUFACTURING PRIMING SET FOR ARTERIAL BLOODLINES

Catalog Number 04-9006-5

Device Problems Air Leak (1008); Device Slipped (1584); Improper Flow or Infusion (2954)

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

Event Date 01/08/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility has reported that during treatment, a roller clamp was not tight enough as the port plug delivers medication and lets the air accumulate in the circuit.The facility reported that 50% of the time, the patient lost a circuit of blood and the other 50% saline was used to return blood back to the patient.They perform 3 - 4 treatments per week and this incident occurred every time this priming set was used.Patient had no adverse effects and required no medical intervention.Sample has not been returned to the manufacturer.This is one of 42 complaints regarding this issue.

Manufacturer Narrative

The 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
• Manufacturer (Section D): REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT, MIKE ALLEN 1331; parque industrial reynosa; reynosa tamaulipas 8878 0; MX 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3912049
• MDR Text Key: 4665479
• Report Number: 8030665-2014-00403
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K010268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Catalogue Number: 04-9006-5
• Device Lot Number: 13DR01024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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
• Treatment: HEMODIALYSIS MACHINE