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

Model Number 2426-0007

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

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

Event Date 10/31/2019

Event Type  malfunction  

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.Although requested, additional information was not provided.

Event Description

Customer advocacy received a copy of the customer's medwatch report from the fda which states, "an iv infusion bolus was started in the emergency department to infused at 999ml/hr for 1 hour.After the infusion rate was decreased to 10 ml per hour.The patient was reviewed, it was noted that the tubing inside the pump had ballooned out in one spot.A new tubing was placed without concerns and worked well without difficulty.Tubing saved adn the emergency room evaluated the lot numbers.They only had one lot number so the report will list the only lot number that is currently available in the emergency department." an incomplete date of event of (b)(6) 2019 was provided.

Manufacturer Narrative

Additional information added; h.6.(patient and device code) ******************************************************************* the customer also reported that the device alarmed when the issue occurred was not confirmed.The root cause could not be determined as the set was compromised during visual inspect ion prior to the additional information that was received and no further testing could be performed.It is likely that the reported alarm was due to the balloon in the silicone tubing.

Event Description

Customer advocacy received a copy of the customer's medwatch report from the fda which states, "an iv infusion bolus was started in the emergency department to infused at 999ml/hr for 1 hour.After the infusion rate was decreased to 10 ml per hour.The patient was reviewed, it was noted that the tubing inside the pump had ballooned out in one spot.A new tubing was placed without concerns and worked well without difficulty.Tubing saved and the emergency room evaluated the lot numbers.They only had one lot number so the report will list the only lot number that is currently available in the emergency department." an incomplete date of event of (b)(6) 2019 2019 was provided.There was no patient harm that was confirmed during follow up.

Event Description

Customer advocacy received a copy of the customer's medwatch report from the fda which states, "an iv infusion bolus was started in the emergency department to infused at 999ml/hr for 1 hour.After the infusion rate was decreased to 10 ml per hour.The patient was reviewed, it was noted that the tubing inside the pump had ballooned out in one spot.A new tubing was placed without concerns and worked well without difficulty.Tubing saved and the emergency room evaluated the lot numbers.They only had one lot number so the report will list the only lot number that is currently available in the emergency department." an incomplete date of event of (b)(6) 2019 was provided.There was no patient harm that was confirmed during follow up.

Manufacturer Narrative

Correction; h.6.(patient code).The customer¿s report that the tubing inside the pump had ballooned out in one spot was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Clear liquid was observed inside the tubing throughout the entire set.At the top of the silicone pump segment tubing near the upper fitment, it was observed that the silicone tubing was softened or weakened.The weakened tubing was also found to be at the location where a balloon would naturally occur.Further visual inspection of the silicone tubing confirmed that the tubing's concentricity was within specification.Previously investigated complaints for this same failure mode determined that the ballooning is caused by excess pressure within the silicone tubing segment.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: 9489615
• MDR Text Key: 196243776
• Report Number: 9616066-2019-03617
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2022
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 19096225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, THERAPY DATE: (B)(6) 2019.
• Patient Age: 17 YR