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

Model Number 2260-0500

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 03/10/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 100 ml bag fresenius kabi ndc 0338-0519-58 lot 10ki9276 exp 08/2018 intralipd 20%; umbilical venous double lumen catheter.Conclusion code field left blank - no available code for undetermined or unknown cause.The report that the bag of intralipids was found empty prematurely could not be confirmed.At 5:48 pm on (b)(6) 2017 an infusion of ivf < 1500 gm was programmed at a rate of 0.4 ml/hr with a vtbi of 8.8 ml (duration of 22 hours).On (b)(6) 2017 at 8:38 am the module alarmed for air in line (ail).The infusion was continued following the ail alarm and between 8:41 am and 10:10 am the ail alarm recurred along with fluid side occlusion alarms.During the alarms the user opened the door and/or restarted the infusion.The volume recorded as infused was 6.497 ml.The cause for the early termination of the infusion could not be determined.Testing and inspection of the pump module identified no malfunctions and the pump module was infusing within specifications.Testing identified leaking from a pinhole in the administration set that may have contributed to the reported event by introducing air into the set or causing the premature emptying of the bag.The customer did not report any signs of a leak having occurred.The proximate cause for the reported event is being attributed to the leak from the pinhole.The cause of the hole was not identified.

Event Description

The customer reported that a critically ill patient was receiving an intralipid infusion at a rate of 0.4 ml/hr, and tpn at 2.7 ml/hr via different lumens of a double lumen umbilical vein catheter.The 100 ml lipid infusion was started on (b)(6) 2017 (at approximately 5 pm), and expected to infuse over approximately 22 hours.The bag was discovered to be empty the following morning at around 8 am at the start of a code resuscitation.The event is estimated to have occurred between 4 to 8 am as previous lab results received at 4 am were normal.After the event, the patient was successfully resuscitated, and no sustained patient effects of the event were reported.

• 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: 6555696
• MDR Text Key: 74772858
• Report Number: 9616066-2017-00771
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2260-0500
• Device Catalogue Number: 2260-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 8015,(2)8100,8110,PRI TUBING,SPM TUBING,TD (B)(6)
• Patient Outcome(s): Required Intervention
• Patient Age: 2 DA
• Patient Weight: 1