MAUDE Adverse Event Report: CAREFUSION HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100B

Device Problem Crack (1135)

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

Event Date 12/04/2013

Event Type  Injury  

Manufacturer Narrative

This initial report was identified as a late submission during a two year retrospective review of complaints and mdr¿s following receipt of an untitled letter issued by the fda.(b)(4).Part/lot were unknown.Faulty parts were not returned for evaluation.

Event Description

The customer reported via e-mail to carefusion: they had five (5) 3100b circuits crack last week on the same patient.They unfortunately did not keep the lot numbers and threw out the circuits because patient was infectious.They report that the cracks were around the cap and diaphragms(4) and (1) by the bellows.Per additional information received on december 11, 2013, rts who were present when the circuits were cracked details to a carefusion representative: it seems that the cracks were due to the way the cases of circuits were handled, perhaps the box was dropped or damaged.Two of the cracks were on the bellows/water trap assembly, the piece that attaches to the circuit.The first crack was noticed when the rt was assembling the circuit and the piece was discarded, with the second one the rt noted that there was a crack on the bellows/water trap assembly but decided to use it anyway as the circuit passed the calibration check.The oscillator was started on the patient, but after 30 minutes of use they were steadily losing paw and they changed the circuit and noted that the crack had got bigger with use.The other 3 were found on the circuit where the cap and diaphragm is attached to the circuit, cracks were visualized on the circuit.The first one was discovered while on the patient and the other 2 on circuits they were going to use to replace the damaged circuit.The patient tolerated bagging while the circuits were replaced.The circuits were all taken into the room and the patient was on isolation, so they considered the circuits contaminated.

• Brand Name: HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 7149227830
• MDR Report Key: 5426471
• MDR Text Key: 37939737
• Report Number: 2021710-2016-03091
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/04/2013

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: 3100B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2013
• Initial Date FDA Received: 02/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention