MAUDE Adverse Event Report: CAREFUSION PRIMARY TUBING SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number PRI TUBING

Device Problems Infusion or Flow Problem (2964); Unintended Movement (3026)

Patient Problems Bradycardia (1751); High Blood Pressure/ Hypertension (1908)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that primary tubing sets roller clamp was released and the patient experienced bradycardia and hypertension.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Rn was in the process of a routine iv tubing change of vasopressin and norepinephrine.Rn connected newly primed tubing of one bag to the pump and incidentally released the roller clamp on the bag not attached to the pump so the patient may have received a small amount of norephinephrine before the bag was reclamped.Patient experienced a short episode of bradycardia and hypertension and recovered.No harm evident, physical or otherwise.

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaint of issues with the roller clamp could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model or lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that primary tubing sets roller clamp was released and the patient experienced bradycardia and hypertension.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Rn was in the process of a routine iv tubing change of vasopressin and norepinephrine.Rn connected newly primed tubing of one bag to the pump and incidentally released the roller clamp on the bag not attached to the pump so the patient may have received a small amount of norephinephrine before the bag was reclamped.Patient experienced a short episode of bradycardia and hypertension and recovered.No harm evident, physical or otherwise.

• Brand Name: PRIMARY TUBING SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10286724
• MDR Text Key: 199283839
• Report Number: 9616066-2020-02244
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRI TUBING
• Device Catalogue Number: PRI TUBING
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other