MAUDE Adverse Event Report: CAREFUSION ALARIS® EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 10011865

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 3ml bd syringe, ref (b)(4), lot 812412c, exp 2021-05-03, 0.9% sodium chloride injection.The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

The customer reported a product used for tpn leaked at the filter.The leak occurred at the "small circle", and the customer is unsure how long the product had been in use.Tpn was infusing at 13ml/hour.The patient also was ordered lipids at 1.4/hour.The patient was not ordered other iv medication.There was no patient harm.

Manufacturer Narrative

Additional information event.

Event Description

The product was received labeled "filter cracked".

Manufacturer Narrative

The patient was an infant.The customer¿s report of a leak at the filter was confirmed.Visual inspection observed fluid residue within the filter.The existing fluid within the syringe was attempted to be pushed through in which the fluid was observed to be leaking out from the vent of the 0.2 micron ped filter.The root cause of the leak was oversaturation of the filter which causes the infusate leak/weep out through the path of least resistance (filter air vent).

Event Description

It was reported that a filtered iv set infusing tpn at 13ml/hr via a 26 gauge picc leaked at the "small circle" of the filter in the nicu.The customer was unsure the length of time the set had been in use.The product was received labeled "filter cracked".In addition to the tpn, lipids were also infusing at 1.4ml/hr; no other medications were ordered.Although requested, there were no additional information or details received from the customer.There was no patient harm.

• Brand Name: ALARIS® EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8237347
• MDR Text Key: 132793304
• Report Number: 9616066-2019-00038
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403233647
• UDI-Public: 10885403233647
• Combination Product (y/n): N
• PMA/PMN Number: K790108
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10011865
• Device Catalogue Number: 10011865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 26 GAUGE PICC, THERAPY DATE UNK; 3ML BD SYRINGE REF 306507, TD UNKNOWN; PRI TUBING; 26 GAUGE PICC, THERAPY DATE UNK
• Patient Age: 15 DA
• Patient Weight: 3