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

Model Number 2426-0007

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2019

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.Ethnicity: not hispanic/latino.Race: (b)(6).

Event Description

It was reported that tubing expanded and ruptured while attached to a pressure infuser set at 2.1ml/sec, for a total volume of 78ml of ct scan imaging dye, with a maximum pressure set of 300psi during a ct scan exam.The roller clamp was closed above the distal port of the primary tubing.A 20 gauge iv in the antecubital vein was used for the injection.There was no patient harm.

Event Description

It was reported that tubing expanded and ruptured while attached to a pressure infuser set at 2.1 ml/sec, for a total volume of 78 ml of ct scan imaging dye, max pressure set at 300 psi during a ct scan exam.The roller clamp was closed above the distal port of the primary tubing.A 20 gauge iv in the antecubital vein was used for the injection.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.

Manufacturer Narrative

The customer¿s report that tubing expanded and ruptured while attached to a pressure infuser set was confirmed.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection noted a section of the tubing was ruptured and deformed that extended 0.4825inches in length.The affected tubing area was weakened or softened from the damage.No other anomalies were observed.Functional testing could not be performed due to the ruptured tubing.The root cause of the ruptured tubing was due to the excessive pressure of 300 psi that exceeded that maximum pressure that the model 2426-0007¿s tubing can handle.

• 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: 9572083
• MDR Text Key: 191576480
• Report Number: 9616066-2020-00060
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• 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: 12/18/2019

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: 2426-0007
• Device Catalogue Number: 2426-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRESSURE INFUSER, THERAPY DATE (B)(6) 2019
• Patient Age: 78 YR
• Patient Weight: 78