MAUDE Adverse Event Report: CAREFUSION CORP ALARIS PUMP MODULE ADMIN SET

Model Number 2433-0007

Device Problems Reflux within Device (1522); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2014

Event Type  Injury  

Event Description

The customer reported that a secondary infusion of sodium phosphate 40 meg/110 ml ns was hung at 1610 on (b)(6) 2014 to infuse over 6 hrs.When the rn checked after 6 hrs it was noted that the secondary had not infused even though the clamps were open and the head height differential appeared to be appropriate.The nurse reprogrammed the infusion and found the infusion was drawing from the primary bag instead of the secondary.The phosphorous level was rechecked.There was no evident effect on the pt.

Manufacturer Narrative

(b)(4).The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

• Brand Name: ALARIS PUMP MODULE ADMIN SET
• Manufacturer (Section D): CAREFUSION CORP; san diego CA
• Manufacturer Contact: michelle bitto ; 10020 pacific mesa blvd; san diego, CA 92121 ; 8586173316
• MDR Report Key: 3843543
• MDR Text Key: 17157802
• Report Number: 9616066-2014-00461
• Device Sequence Number: 1
• Product Code: FPB
• 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: Other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2433-0007
• Device Catalogue Number: 2433-0007
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2014
• 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: ALARIS PUMP MODULE, SN (B)(4); ALARIS PC UNIT, SN (B)(4); SEDONDARY SET, MFR/MODEL/LOT UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 71