MAUDE Adverse Event Report: CAREFUSION MICROBORE EXTENSION SET, IV CONNECTOR; SET, EXTENSION, INTRAVASCULAR

Model Number MZ9226

Device Problems Occlusion Within Device (1423); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)

Patient Problem No Code Available (3191)

Event Date 10/20/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion code: field left blank- no available code for undetermined or unknown cause.The customer¿s report that the pump alarmed for occlusion could not be confirmed because the device was not returned for investigation.The report of being unable to manually push medication through the tubing was confirmed.Visual inspection of the set revealed evidence of dried fluid throughout the set¿s components.No obvious damages or other issues were observed.Functional testing resulted in initial resistance until more pressure was applied onto the syringe plunger; then the fluid was able to flow through and exit the distal luer end as expected.The probable cause of the reported event is medication clogging within the tubing.The root cause of the crystallization and clogging is unknown.

Event Description

The customer reported that a syringe pump infusing pentobarbital through a peripheral iv alarmed twice for occlusion.The clinician checked the iv, took the syringe out of the pump and tried manually pushing the medication through the tubing without success.The iv was flushed and had a positive blood return.Small crystals were noted in the tubing with the filter.Multiple prn sedation boluses were given over a several hour period in an attempt to better sedate the patient.The customer stated that there was no injury to the patient.

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR
• Type of Device: SET, EXTENSION, 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: 7101005
• MDR Text Key: 94278177
• Report Number: 9616066-2017-01623
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143234
• 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: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ9226
• Device Catalogue Number: MZ9226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• 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: 8110,SYR TUBE,8015,SYRINGE, TD (B)(6)
• Patient Outcome(s): Required Intervention