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

Model Number 11532269

Device Problems False Alarm (1013); Insufficient Flow or Under Infusion (2182); No Flow (2991)

Patient Problem No Information (3190)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.Additional patient information: diagnosis: rectal cancer.

Event Description

It was reported that the patient was to receive a cetuximab chemotherapy infusion for the duration of 2 hours.Approximately half way through the infusion, the device began to continually alarm and would not infuse the medication.The nurse switched out the devices three separate times and the devices continued to experience nuisance alarms.The nurse removed the non-absorbing iv tubing set and replaced it with a regular tubing set and the infusion was able to complete without difficulty.The infusion was delayed and instead of taking 2 hours to infuse, it took five hours.

• 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
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8921886
• MDR Text Key: 155267493
• Report Number: 9616066-2019-02397
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232343
• UDI-Public: 10885403232343
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11532269
• Device Catalogue Number: 11532269
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (3) 8100, (3) 8015, THERAPY DATE (B)(6) 2019
• Patient Age: 39 YR