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

Model Number	11404930
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
It was reported that the tubing ballooned in the pump segment.Medication infusing at the time was an antibiotic.There were no issues after the tubing was replaced.Received a copy of the customer's sus voluntary event report from fda which states, ¿tubing bubbled out during administration.Tubing was on a pump with antibiotic.".
Additional Manufacturer Narrative
The customer¿s report that the tubing ballooned in the pump segment was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.During inspection it was observed that the silicone segment tubing had a slight bulge, discoloration, and was weakened just below the upper fitment.Clear liquid was observed inside the set¿s tubing and drip chamber.No other abnormalities were observed on the set during visual inspection.The silicone segment was analyzed and the walls were found to be concentric.The ballooning is caused by excess pressure within the silicone tubing segment.The root cause for the source of the excessive pressure is unknown.
Event or Problem Description
It was reported that the tubing "ballooned" in the pump segment.Medication infusing at the time was an antibiotic.There were no issues after the tubing was replaced.Although requested, there is no further patient or event information available.Received a copy of the customer's sus voluntary event report from fda which states, ¿tubing bubbled out during administration.Tubing was on a pump with antibiotic.".
Event or Problem Description
It was reported that the tubing "ballooned" in the pump segment.Medication infusing at the time was an antibiotic.There were no issues after the tubing was replaced.Although requested, there is no further patient or event information available.Received a copy of the customer's sus voluntary event report from fda which states, ¿tubing bubbled out during administration.Tubing was on a pump with antibiotic.".
Event or Problem Description
It was reported that the tubing "ballooned" in the pump segment.Medication infusing at the time was an antibiotic.There were no issues after the tubing was replaced.Although requested, there is no further patient or event information available.Received a copy of the customer's sus voluntary event report from fda which states, ¿tubing bubbled out during administration.Tubing was on a pump with antibiotic.".

• 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: 9275554
• Report Number: 9616066-2019-03126
• Device Sequence Number: 11364912
• Product Code: FPA
• UDI-Device Identifier: 07613203021197
• UDI-Public: 7613203021197
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11404930
• Device Catalogue Number: 11404930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 01/06/2020; 01/10/2020; 01/21/2020
• 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: 8100,8015, THERAPY DATE: UNK.; THERAPY DATE: (B)(6) 2019.