MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRESSURE INFUSION BAG; INFUSOR, PRESSURE, FOR I.V. BAGS

Catalog Number PIB500

Device Problems Air Leak (1008); Loss of or Failure to Bond (1068)

Patient Problem Misdiagnosis (2159)

Event Date 05/15/2014

Event Type  Injury  

Event Description

It was reported that a patient's blood pressure appeared to drop slightly on the monitoring equipment.The patient received a low dose of medication for drop in pressure.It was identified that the pressure infusion was part of the pressure monitoring system.The measured drop in blood pressure was attributed to the loss of pressure in the bag.Multiple attempts were made to get clinical details from a medical professional without success.No further harm or injury to the patient was reported.

Manufacturer Narrative

The user reported a second lot number (i677857) with a manufacturing date of april 18, 2014 and an expiration date of march 31, 2014.Device evaluation: the suspect device has not been returned for evaluation.A follow up report will be submitted when the evaluation has been completed.

• Brand Name: PRESSURE INFUSION BAG
• Type of Device: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• Manufacturer Contact: jerry mcphie ; 1600 west merit pkwy.; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 3940692
• MDR Text Key: 4530624
• Report Number: 1721504-2014-00118
• Device Sequence Number: 1
• Product Code: KZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: PIB500
• Device Lot Number: I668545
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention