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

Model Number 2426-0007

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hypoglycemia (1912)

Event Date 11/16/2016

Event Type  Injury  

Manufacturer Narrative

Customer mw # 5066274.Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

The customer reported that the patient had d-10 in ½ ns infusing, however her blood sugars had remained low; she was given three individual d-10 boluses and the iv fluid rate was increased.Initially when the iv was checked by the nurse there was no leaking noted, however at the time the third d-10 bolus was started the nurse noted that the patient¿s bedding was wet, and they saw fluid coming out of the distal injection port.The tubing was replaced, the third bolus was completed, and the patient¿s subsequent blood sugar was 241.Received a copy of the customer's medwatch report from the fda which states, "ft bs low since 0600 when gas checked.Iv fluids increased and bs rechecked in 1 hour bs lower than before.D10 bolus given but bs lower on recheck again.Iv checked not leaking from the site.Bs rechecked again and again low not improving.Another d10 bolus given.Bs remained low despite d10 boluses.Iv checked again noticed blankets on pt mattress noticeably wet.Started a 3rd d10 bolus and felt fluid up against my arm.Looked at iv site again ok, so followed up the tube and noticed fluid shooting out of the port site closest to pt on iv tubing.Tubing switched out a d pt given 3rd bolus and iv fluids increased.Bs recheck after tubing switch out was 241.".

• 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
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 6185381
• MDR Text Key: 62716014
• Report Number: 9616066-2016-01766
• Device Sequence Number: 1
• Product Code: FPA
• 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: Other
• Type of Report: Initial
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 25 DA
• Patient Weight: 3