MAUDE Adverse Event Report: CAREFUSION MINIBORE PRESSURE RATED EXT, IV CNNCTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MZ5307

Device Problem Fluid/Blood Leak (1250)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Manufacturer Narrative

Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.

Event Description

The information received suggests that the device leaked during infusions of noradrenaline and adrenaline on a very unstable patient.The patient had significant fluctuations in blood pressure and required adrenaline boluses.The customer later suspected that this may have been due to a leak in the set, although no leak was noted at the time of the event.

Manufacturer Narrative

The reported complaint could not be confirmed.A visual inspection of the used mz5307 samples did not identify any anomalies.Functional testing of both samples was performed and no anomalies were found.Pressure testing was also performed and no anomalies were found.The root cause could not be identified.

• Brand Name: MINIBORE PRESSURE RATED EXT, IV CNNCTOR
• 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: mustafa omar ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7430690
• MDR Text Key: 105503063
• Report Number: 9616066-2018-00470
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ5307
• Device Catalogue Number: MZ5307
• Device Lot Number: 17036946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 05/18/2018
• Supplement Dates FDA Received: 05/24/2018
• 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
• Patient Outcome(s): Required Intervention