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

Model Number 2420-0007

Device Problems Material Rupture (1546); Stretched (1601); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Patient's demographics requested, but was not provided.

Event Description

It was reported that the line occluded and when the rn opened the pump module door the iv tubing set was found to have a balloon in the silicone segment that " burst".

Event Description

It was reported that the line occluded and when the rn opened the pump module door the iv tubing set was found to have a balloon in the silicone segment that " burst".There was no patient impact.

Event Description

It was reported that the line occluded and when the rn opened the pump module door the iv tubing set was found to have a "balloon" in the silicone segment that " burst".It was confirmed that there was no patient impact related to this event.

Manufacturer Narrative

The customer¿s report that the line occluded was not confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted separation between the silicone pump segment and the upper fitment.The ring retainer was not received with the set however a ring retainer indentation was observed at the end of the silicone segment indicating the set had been assembled with the ring retainer.The silicone tubing pump segment distal to the upper fitment was slightly stretched and misshapen, had a different appearance than the rest of the silicone tubing, and readily kinked and twisted.Examination under magnification found the silicone segment to be concentric.The customer¿s report that the line ¿burst¿ was confirmed to be a separation.The root cause of the separated tubing is due to a balloon segment forming and then ¿bursting¿ due to the excess pressure.The root cause for the source of the excessive pressure is unknown.

• 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: 9345005
• MDR Text Key: 189760501
• Report Number: 9616066-2019-03366
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• 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: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR