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

Model Number 11607704

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported that shortly after initiating an antibiotic infusion, the pump alarmed "air in line".Upon investigation it was found that there was a small hole in the tubing and the antibiotic had leaked onto the floor and wall.The md was notified because the patient did not receive the full antibiotic dose.There was no report of patient harm.

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 drug involved was zosyn.

Event Description

Zosyn 3.375g/50ml antibiotic infusion.

Manufacturer Narrative

The customer¿s report of hole in tubing and set leaked was confirmed.Visual inspection of the set noted that the silicone segment had a 0.1226 inch tear near the upper fitment.Examination under magnification noted no crush marks to the upper blue fitment.No other anomalies were observed.Functional and pressure testing confirmed leaking coming out from the silicone tubing near the upper fitment.The root cause of the leak was due to a tear in the silicone segment.The cause of the tear is unknown.

• 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
• MDR Report Key: 7321927
• MDR Text Key: 101978684
• Report Number: 9616066-2018-00242
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11607704
• Device Catalogue Number: 11607704
• Other Device ID Number: 10885403228001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 03/12/2018; 04/09/2018
• Supplement Dates FDA Received: 03/22/2018; 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 11448964,500ML BAXTER BAG,50ML PFIZER BAG; 8015,8100, THERAPY DATE (B)(6) 2018