MAUDE Adverse Event Report: BAXTER HEALTHCARE - HAINA EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C5647

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Respiratory Distress (2045); Weakness (2145)

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient was using an intravenous (iv) extension set to infuse a post-operative iv of acetaminophen at a rate of 100 or 200 milliters over 15 minutes (no further detail).It was reported that the blue cap that was over the ¿other y-site¿ (not further specified) was not tight onto the site and allowed air to enter into the line during the infusion.It was stated that air entered the patient for an unknown amount of time (stated as approximately 15-60 minutes).The patient went into respiratory distress due to the event.The patient was given oxygen via a cpap (continuous positive airway pressure) machine.Narcan was also administered to the patient (dose, frequency and route were not reported).Afterwards, the patient complained of weakness in their left arm.The patient's left arm function eventually returned to normal, and the patient recovered from the event.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, a photograph of the sample was provided for evaluation.The photo/video sample was visually inspected using naked eye, air bubbles were observed in the tubing below the y-site.The cause could not be determined since the actual sample was not evaluated.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - HAINA; haina, san cristobal
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA; piisa industrial park antigua; carretera sanchez km 18 1/2; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7484237
• MDR Text Key: 107266610
• Report Number: 1416980-2018-02567
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412031569
• UDI-Public: (01)00085412031569
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2023
• Device Catalogue Number: 2C5647
• Device Lot Number: DR18A25013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 05/16/2018
• Supplement Dates FDA Received: 06/04/2018
• 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: N
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; BAXTER SIGMA PUMP
• Patient Outcome(s): Required Intervention