MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 11607704

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tachycardia (2095)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

No product will be returned.The customer¿s complaint could not be confirmed because the product will not be returned for failure investigation.The root cause of this failure was not identified.Although requested, no patient demographics provided.

Event Description

It was reported there were air-in-line alarms.The nurse tried three different pcus and five different lvps, as well as two different tubing sets.As a result of the event, the patient's heart rate increased, requiring a repeat bolus of cardizem.The patient's heart rate started at 156 bpm to 142 bpm during the event.A bolus dose of 25 mg of cardizem was administered and the heart rate decreased to 110 bpm.

Event Description

It was reported there were air-in-line alarms.The nurse tried three different pcus and five different lvps, as well as two different tubing sets.As a result of the event, the patient's heart rate remained increased, requiring a repeat bolus of cardizem.The patient's heart rate started at 156 bpm but remained elevated at 142 bpm during the air-in-line alarms.A bolus dose of 25 mg of cardizem was administered and the heart rate decreased to 110 bpm.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9860849
• MDR Text Key: 184387236
• Report Number: 9616066-2020-01086
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403228001
• UDI-Public: 10885403228001
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

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: 11607704
• Device Catalogue Number: 11607704
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (5)8100, (3) 8015,THERAPY DATE (B)(6) 2020
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 66