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

Catalog Number 04-9006-5

Device Problems Air Leak (1008); Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

The user facility reported that the connection to the bloodline is not sealing tightly, causing leaking of normal saline and therefore contributing to more incidents of air in blood.It is currently unknown how many incidents occurred, or whether the machine(s) alarmed "air in blood" and shut down as intended.A sample is available.

Manufacturer Narrative

Attempts to obtain additional information have been made with no further details provided.This report includes all information received to date.Due to the lack of information, this mdr is being filed as an adverse event and product problem.The device has not yet been received for physical evaluation.A plant investigation is still ongoing and a supplemental report will be submitted upon completion.

• Brand Name: PRIMING SET FOR ARTERIAL BLOODLINES
• Manufacturer (Section D): REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque ind. reynosa sur, brecha e-99; apartado postal #326; reynosa, tamps. 8878 0; MX 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451 ; 7816999751
• MDR Report Key: 3591463
• MDR Text Key: 17156360
• Report Number: 8030665-2014-00047
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• PMA/PMN Number: K010268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Catalogue Number: 04-9006-5
• Device Lot Number: 13KR01247
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2013
• 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: UNKNOWN HEMODIALYSIS MACHINE