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

Model Number PRI TUBING

Device Problem False Alarm (1013)

Patient Problem No Information (3190)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

Product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Patient's demographics requested, but not provided.

Event Description

It was reported air in line alarms that have increased over the past several months, possible due to set separated from drip chamber from previous complaint that caused air-in-line alarms.

Event Description

It was reported air in line alarms that have increased over the past several months, possible due to set separated from drip chamber from previous complaint that caused air-in-line alarms.

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.A2: patient's demographics requested, but not provided.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8994562
• MDR Text Key: 157478292
• Report Number: 9616066-2019-02565
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRI TUBING
• Device Catalogue Number: PRI TUBING
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 8100, 8015, THERAPY DATE (B)(6) 2019; 8100, 8015, THERAPY DATE (B)(6) 2019