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

Model Number	11607704
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem 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 or Problem 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9860781
• Report Number: 9616066-2020-01084
• Device Sequence Number: 2663845
• Product Code: FPA
• UDI-Device Identifier: 10885403228001
• UDI-Public: 10885403228001
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 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
• Operator of Device: Health Professional
• Device Model Number: 11607704
• Device Catalogue Number: 11607704
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 05/04/2020
• 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: (5) 8100, (3) 8015,THERAPY DATE (B)(6) 2020
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 66