MAUDE Adverse Event Report: CAREFUSION ALARIS SYRINGE ADAPTER SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 10010483

Device Problems Disconnection (1171); Insufficient Flow or Under Infusion (2182)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); No Code Available (3191)

Event Date 05/04/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: central line;syringe; therapy date (b)(6) 2019.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.

Event Description

It was reported that a patient did not receive adequate fentanyl sedation resulting in agitation by the patient, and an increase in ventilator alarms.The patient 'nearly coded' 2 times, and became hypotensive with a systolic blood pressure in the 50's.The patient was also bradycardic in the morning with a heart rate in the 40's.In the afternoon, the patient's oxygen desaturated to the 40's.The patient was agitated with ventilator alarms despite being placed on a fentanyl drip.When the nurse checked on the patient to increase the sedation, it was noted that the fentanyl syringe was laying on top of the device (disconnected), even though the device continued to infuse without an alarm via a central line.Subsequently, the patient desaturated again and was ventilated with a resuscitator bag.It was not determined if the desaturation was from a mucus plug, or due to severe agitation and ongoing patient/vent asynchrony.The defective tubing was then run in another device without the syringe, and that device did not alarm either.Although requested, there was no further information provided regarding this event.

Event Description

It was reported that a patient did not receive adequate fentanyl sedation resulting in patient agitation, and increased ventilator alarms.The patient 'nearly coded' 2 times, and became hypotensive with a systolic blood pressure in the 50's.The patient was also bradycardic in the morning with a heart rate in the 40's.In the afternoon, the patient's oxygen desaturated to the 40's.The patient was agitated with ventilator alarms despite being placed on a fentanyl drip via a central line.When the nurse checked on the patient to increase the sedation, it was noted that the fentanyl syringe was laying on top of the device (disconnected), even though the device continued to infuse without an alarm.Subsequently, the patient desaturated again and was ventilated with a resuscitator bag.It was not determined if the desaturation was from a mucus plug, or due to severe agitation and ongoing patient/vent asynchrony.The defective tubing was then run in another device without the syringe, and that device did not alarm either.

Manufacturer Narrative

Bd syringe, fentanyl 1000 microgram/20ml.The customer¿s report of the syringe disconnection was confirmed.Visual inspection of the set noted the pump chamber upper fitment was broken off at the bottom of the vented spike of the set.Part of the spike¿s connection pivot was inside the upper fitment.Examination under magnification observed evidence of possible degradation of the acrylic surfaces.Functional testing was not performed due to the damage to the vented spike.The cause of the syringe disconnection was due to the pump chamber upper fitment being broken off at the bottom of the set¿s vented spike.The root cause of the broken upper fitment at the bottom of the vented spike was not determined.

• Brand Name: ALARIS SYRINGE ADAPTER SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8663014
• MDR Text Key: 146808686
• Report Number: 9616066-2019-01488
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232602
• UDI-Public: 10885403232602
• Combination Product (y/n): N
• PMA/PMN Number: K934095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

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 Model Number: 10010483
• Device Catalogue Number: 10010483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8100,PRI TUBING, THERAPY DATE 5/4/19; BD 20ML SYRINGE; 8015,8100,PRI TUBING, THERAPY DATE: (B)(6) 2019
• Patient Outcome(s): Required Intervention