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

Model Number 2420-0007

Device Problem Fluid/Blood Leak (1250)

Patient Problem Death (1802)

Event Date 12/31/2015

Event Type  Death  

Manufacturer Narrative

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.

Event Description

The customer reported that an (unspecified) "standard concentration" of norepinephrine was infusing at 20mcg/min as a primary infusion.An increased concentration was ordered therefore both the bag and tubing were changed and the infusion was started.After a short time the patient became hypotensive and the dose was increased as ordered.The patient became progressively hypotensive; the dose was titrated to the maximum allowed dose, without effect.When the nurse assessed the line for a possible disconnection she identified a leak coming from the tubing; another nurse immediately primed a new set and when the set in question was disconnected the nurse observed a hole in the tubing approximately 1-2 cm above the y connector closest to the patient.The patient subsequently went into cardiac arrest; it was initially reported that there was no lasting effect on the patient as a result of the leak, however there is an unsubstantiated anecdotal report that the patient died 2 days later.Although requested the customer has declined to provide any further event or outcome details.

Event Description

Received a copy of the customer¿s medsun report which states ¿the rn changed he alaris pump tubing for levophed drip.After priming the tubing the rn placed the new tubing in the alaris pump chamber and continued the drip at the ordered dose.The patient became hypotensive.The rn increased the rate to achieve the adequate bp per order.The bp continued to decrease.The rn noted the tubing was fractured distal to the y connector.New tubing was replaced and the bp returned to previous within minutes.¿.

• 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5383661
• MDR Text Key: 36550883
• Report Number: 9616066-2016-00084
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CT
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/01/2018
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 15107250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2015
• 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): Death
• Patient Age: 74 YR