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

Model Number 2420-0007

Device Problem Stretched (1601)

Patient Problem No Information (3190)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

The customer's report of the tubing ballooning was confirmed.The as-received set sample was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.It was identified during inspection of the as-received set sample that there was a bulge along the silicone segment.No other issues were observed with the set sample.Previously investigated complaints for this failure mode determined that the bulge is caused by excess pressure within the silicone segment.The root cause for the source of the excessive pressure is unknown.

Event Description

It was reported that a set primed by the anesthesia department "ballooned", at the pump segment.Although requested, there is no further patient or event information available.

Manufacturer Narrative

The customer report of tubing ballooning was confirmed.The as-received set sample was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No other issue was observed.It was identified during inspection of the as-received set sample that there was a bulge along the silicone segment.Previously investigated complaints for this failure mode determined that the bulge is caused by excess pressure within the silicone segment.The root cause for the source of the excessive pressure is unknown.

Event Description

It was reported that a set primed by the anesthesia department "ballooned", at the pump segment.Although requested, there is no further patient or event information available.

Manufacturer Narrative

Continued from d.11: non-bd extension set;b braun stopcock; td (b)(6) 2019 possible lot number of the suspect device: 19103348.

Event Description

It was reported that a set primed by the anesthesia department "ballooned", at the pump segment.Although requested, there is no further patient or event information available.

• 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: 9540769
• MDR Text Key: 191415151
• Report Number: 9616066-2019-03808
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• 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,Followup
• Report Date: 12/12/2019

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
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/07/2020; 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: B BRAUN STOPCOCK (ONE CLEAR CAP), TD (B)(6) 2019.