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

Catalog Number	2C5647
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Respiratory Distress (2045); Weakness (2145)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem 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.
Additional 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - HAINA; haina, san cristobal
• MDR Report Key: 7484237
• Report Number: 1416980-2018-02567
• Device Sequence Number: 13479996
• Product Code: FPA
• UDI-Device Identifier: 00085412031569
• UDI-Public: (01)00085412031569
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2023
• Device Catalogue Number: 2C5647
• Device Lot Number: DR18A25013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN; BAXTER SIGMA PUMP
• Outcome Attributed to Adverse Event: Required Intervention