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

Model Number 10010454

Device Problems Insufficient Flow or Under Infusion (2182); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); Underdose (2542)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was requested, but not provided.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.A follow up report will be submitted with failure investigation results should the product be received for evaluation.

Event Description

It was reported that filter not filling as expected and does not appear to be filtering product (product does not slow after going through filter, air bubbles in filter, or medication only filling on 1 side.Due to re-priming in attempt to find a working iv administration set, medication was lost in the process.This resulted in the patient not receiving a full dose/full nutrition for the day (medication was total parenteral nutrition).It was reported that patient care was not delayed and it did not contribute to, or result in serious adverse impact to patient.

Event Description

It was reported that the tubing set filters are not filling as expected and do not appear to be filtering products (product does not slow after going through filter, air bubbles in filter, or medication only filling on 1 side) during tpn administrations.Due to re-priming of a new administration set, medications are lost in the process which results in the infant patients not receiving a full dose/full nutrition for the day (medication was total parenteral nutrition).It was later reported that there was no delayed patient care, nor did the event contribute to, or result in serious adverse impact to any patients.

Manufacturer Narrative

Additional information added; d10.The customer¿s report that the tubing set filters were not filling was confirmed.However, the filters¿ air vents were occluded from previous vent leakages which prevented air boluses from exiting the filters.Visual inspection under a lab microscope found evidence of leakage on each of the set¿s air filter membranes.The filter membranes were compromised with dried liquid obstructing the air vents.No other anomalies or evidence of damage were observed on the filters or the sets during initial visual inspection.It was observed that one of the three returned sets leaked out (termed ¿weeping out¿) from the air vents of the primary set¿s micron adult filter.The sets were visually inspected for obvious damage such as cracks, kinks, holes, and tears in the tubing and its components.Functional testing was performed by spiking each set to a lab iv bag filled with bleach water.The customer reported that the filters are not filtering was not confirmed.The root cause of the customer¿s experience was not identified as the sets re-primed during functional testing with no visual particulates exiting the sets.The root cause of the leakage was not identified.

Event Description

It was reported that the tubing set filters are not filling as expected and do not appear to be filtering products (product does not slow after going through filter, air bubbles in filter, or medication only filling on 1 side) during tpn administrations.Due to re-priming of a new administration set, medications are lost in the process which results in the infant patients not receiving a full dose/full nutrition for the day (medication was total parenteral nutrition).It was later reported that there was no delayed patient care, nor did the event contribute to, or result in serious adverse impact to any patients.

Manufacturer Narrative

Functional testing was performed by spiking each set to a lab iv bag filled with bleach water.An 18-gauge cannula was attached to each of the primary sets¿ male luers.One clean and empty lab beaker was stationed at the exit ports of the cannulas to verify if any particulates are bypassing the filters.The sets re-primed slowly while one of the two sets observed small droplets from the micron filter¿s air vents (termed ¿weeping out¿).It was also noted that during re-priming of the sets, the filter air vents were obstructed from the previously dried fluid and air boluses were unable to exit the filters, confirming the customer¿s report of filters not filling.By design, the filters did not allow air boluses to pass the filter with the occluded air vents.No other leaks or issues were observed.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9491490
• MDR Text Key: 191110896
• Report Number: 9616066-2019-03708
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203015806
• UDI-Public: 7613203015806
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2019

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: 08/12/2022
• Device Model Number: 10010454
• Device Catalogue Number: 10010454
• Device Lot Number: 19085893
• 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