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

Model Number 10010453

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem Blood Loss (2597)

Event Date 01/25/2020

Event Type  malfunction  

Manufacturer Narrative

Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Per previous discussion with the customer, it is their policy not to provide patient demographics.

Event Description

It was reported that the tubing separated at filter while total parenteral nutrition (tpn) was infusing through iv pump.The tpn was programmed to infuse 1,200ml over 24 hours through central venous line and the event occurred 4 hours into infusion.The patient lost some amount of blood and the tpn bag had to be discarded, which led to interruption on the patient's nutrition intake.There was no patient injury and no additional medical intervention required.It was then reported that the patient received subsequent tpn infusion 12 hours after the event.Although requested, additional information was not provided.

Event Description

It was reported that the tubing separated at filter while total parenteral nutrition (tpn) was infusing through the iv pump.The (tpn) was programmed to infuse 1at ,200ml over (24) hours through central venous line and the event occurred (4) hours into infusion.The patient lost some amount of blood and the (tpn) bag had to be discarded, which led to an interruption on the patient's nutrition intake.There was no patient injury and no additional medical intervention required.It was then reported that the patient received subsequent (tpn) infusion (12) hours after the event.Although requested, additional information was not provided.

Manufacturer Narrative

Additional information provided: d.10.The customer's report that the tubing separated from the filter and leaked was confirmed.Visual inspection of the set noted separation at the engagement of the outlet of the adult micron filter and expected pvc tubing sleeve.The rest of the expected components below the filter were not received for evaluation.No other obvious issues were observed.Testing was deemed unnecessary due to separation.The cause of the leak was due to the noted separation.The root cause of the separation was not identified.

• 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: 9716785
• MDR Text Key: 190049048
• Report Number: 9616066-2020-00472
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021135
• UDI-Public: 7613203021135
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2022
• Device Model Number: 10010453
• Device Catalogue Number: 10010453
• Device Lot Number: 19076460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, THERAPY DATE (B)(6) 2020.