MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. PORTEX CUSTOM SINGLE LIMB CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C1110

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

The customer reported disconnecting or loose connection points resulting in a leak alarm on the portex single limb circuit.The issues were noticed nearly immediately.No patient or clinical injury reported.Additional information has been requested.

Manufacturer Narrative

One portex® custom single limb circuit was returned for investigation.The device was received inside a plastic bag with its original closed packaging.The customer reported that two devices contributed to two reported events (one device per event).The customer returned one device for evaluation.It could not be determined which reported occurrence that device was associated with; therefore, the evaluation of the device will be used for the medwatch.The following mfr were submitted related to the evaluation: 2183502-2016-01667 and 2183502-2016-01668.Visual inspection found no deformations/holes along the tube and the device was correctly assembled; no defects were observed.Additionally, no holes were found on the breathing bag.During functional testing, the returned tube and bag were connected to the leak tester device; no leaks were detected.The returned device then underwent a retention and bond strength test using a calibrated weight and brackets.During the strength and bond test, no separation on the parts or on the bonding was observed.After the strength and bond test, the tube and bag were re-connected to the leak testing device; no leaks were observed.Investigation was unable to find fault with the returned device and found that the device operated as intended.(b)(4).

• Brand Name: PORTEX CUSTOM SINGLE LIMB CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana 55425 ; MX 55425
• Manufacturer Contact: lisa perz ; 1265 grey fox rd; st. paul, MN 55112 ; 7633833074
• MDR Report Key: 5848481
• MDR Text Key: 51227202
• Report Number: 2183502-2016-01668
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C1110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2016
• 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: Unknown
• Patient Sequence Number: 1