MAUDE Adverse Event Report: CAREFUSION/BD ANES CIRCUIT, 120 IN EXP, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number AMY520X4F

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer has not notified carefusion/bd if the affected device is available for investigation.A ups label was provided to the customer.At this time we are currently waiting for the sample.Once the investigation is complete or if we receive any additional information we will provide a follow up emdr.(b)(4).

Event Description

Customer reported that ¿there was a slit in the tubing near the end.My resident and i induced general anesthesia and when we went to ventilate the patient we could not because we could not generate positive pressure.We looked at all the machine connections to see if one of the circuit arms had been disconnected but they were not.As i was searching for an "ambu bag" my resident noticed that there was a separation in the plastic of the circuit.We did not notice it on the first glance because the circuit arm was still connected to the machine and that separation in the plastic was hard to notice and a rare spot for there to be a problem.We changed the circuit quickly and then were able to ventilate the patient.The scariest part was that by the time we figured out that defect in the circuit, the patient had not been breathing for a long time and had de-saturated to 40%.I've never seen a defect in a circuit at that spot.It looked like a clean separation not like it had ripped.".

Manufacturer Narrative

A physical sample was not provided by the end-user, only a photograph of the device showing the defect of the reported issue.In order to determine the exact root cause a physical sample is needed.However according to the photograph provided it showed that the hose was completely detached from the connector.The device history record was reviewed for the lot number reported, and no issues were found that may have contributed to this issue.The product was inspected and released in accordance with our internal producers.Two years of complaint data from (b)(6) 2015 to (b)(6) 2017 were reviewed and no trend was identified.There is no indication that the reported issue was caused by the manufacturing process.During the investigation attempts to replicate the failure with different conditions to the manufacturing process were performed.The only way the reported issue could be replicated was by making a small incision inside the corrugation on the hose and then pulling it apart.However, this replication cannot be found in any of the manufacturing processes, therefore it is not considered that the process could cause the failure reported.

• Brand Name: ANES CIRCUIT, 120 IN EXP, 3L BAG
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): CAREFUSION/BD; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): CAREFUSION/BD; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 75 n. fairway dr.; vernon hills, IL 60061
• MDR Report Key: 6416822
• MDR Text Key: 70317533
• Report Number: 8030673-2017-00307
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AMY520X4F
• Device Lot Number: 0001028448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention