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

Model Number 2123-0007

Device Problems Fluid/Blood Leak (1250); Split (2537); Torn Material (3024)

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

Event Date 05/02/2016

Event Type  malfunction  

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 upon opening the door of the pump to troubleshoot ail alarms, a split in the tubing at the silicone segment with leaking was noted in the tubing.There was no patient harm reported.

Manufacturer Narrative

Conclusion code: field left blank- no available code for undetermined or unknown cause.The customer¿s report of leak at silicone segment was confirmed.During visual inspection of the set it was noted that the silicone segment part number had a tear near the upper fitment.The tear was measured to be 0.334mm long.Visual examination under magnification observed a crush mark to the upper blue fitment.No other anomalies were noted.Functional and pressure testing confirmed leaking coming out from the silicone tubing near the upper fitment.No other anomalies were noted on the set.The root cause of the leak was due to a tear in the silicone segment.The cause of the tear is unknown.

Manufacturer Narrative

Additional medwatch information provided.

Event Description

Medwatch: ¿patient was new post-op, new iv fluids hung on alaris pump, no leaks or drips detected.Alaris infusion pump began alarming, it was noted the air was in the line directly after the infusion chamber.When opened the chamber was noted to be wet.Tubing appeared to be split or cracked in soft infusion area.Tubing was saved to be investigated.".

• 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: 5728170
• MDR Text Key: 47494091
• Report Number: 9616066-2016-00767
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2016

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: 2123-0007
• Device Catalogue Number: 2123-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2016
• Initial Date FDA Received: 06/15/2016
• Supplement Dates Manufacturer Received: Not provided; 07/20/2017
• Supplement Dates FDA Received: 08/26/2016; 07/25/2017
• 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
• Patient Age: 4 MO