MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER; CATHETER, FLOW DIRECTED

Model Number 831F75

Device Problems Excess Flow or Over-Infusion (1311); No Device Output (1435)

Patient Problems High Blood Pressure/ Hypertension (1908); No Consequences Or Impact To Patient (2199)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon- the return of the product a supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported that an issue occurred while trying to obtain a cardiac output (co) measurement on a patient with a swan-ganz catheter.The patient was receiving an infusion of noradrenaline via the proximal infusion port at the time of the event.As the clinician was pushing a 10ml injectate bolus via the proximal injectate port, the patient's blood pressure rose dramatically, which the clinician believed but could not confirm may have been due to a flush of noradrenaline.The attempt to obtain cardiac output was ceased and not performed again.The swan-ganz catheter was removed.There was no allegation of patient injury.Patient demographics were requested and not provided.The lot number was unknown.

Manufacturer Narrative

Per additional follow-up with the customer, it was clarified that the cardiac output (co) measurement was being performed using a 10ml bolus of saline solution via the ¿proximal injectate port¿ and the noradrenaline infusion was running via the ¿vip lumen hub¿.It is unknown if there was an internal communication between the two lumens, but the outcome of injecting the 10mls of saline solution via the injectate port resulted in the patient becoming hypertensive.The patient¿s rise in blood pressure did not require treatment.The exact lot number of the suspect device was unknown, though the customer provided 3 potential lot numbers from what remained of their shelf stock.A device history review has been initiated to document that the devices met all specifications upon distribution.

Manufacturer Narrative

A device history record review was completed for all three possible reported lot numbers and documented that the device met all specifications for each upon distribution.Potential lot number 61563690: udi (b)(4), (01)50690103003036(17)201029(11)181030(10)61563690; manufacturing date 11/02/2018; expiration date 10/29/2020.Potential lot number 61563689: udi (b)(4), (01)50690103003036(17)201028(11)181029(10)61563689; manufacturing date 11/02/2018; expiration date 10/28/2020.Potential lot number 61543343: udi (b)(4), (01)50690103003036(17)201004(11)181005(10)61543343; manufacturing date 10/08/2018; expiration date 10/04/2020.

Manufacturer Narrative

Our product evaluation laboratory received one model 831f75 swan-ganz catheter with a 1.5ml monoject syringe and non-edwards contamination shield.As received, all through lumens were patent without any leakage or occlusion.No fault messages showed up when connected to the lab vigilance ii monitor.The thermistor was found to read 37.0°c when submerged into a 37.0°c water bath.The balloon inflated clear and concentric, and remained inflated for more than 5 timed minutes without leakage.No visible damage was observed from the catheter body.A device history record review was completed for all reported lot numbers and documented that the device met all specifications upon distribution.The customer report of a flushing issue was not confirmed on evaluation, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Invasive procedures involve some patient risks.Although serious complications associated with pulmonary artery catheters are relatively uncommon, the physician is advised before deciding to use the catheter to consider and weigh the potential benefits and risks associated with the use of the catheter against alternative procedures.The general risks and complications associated with indwelling catheters are well documented in the literature.It is standard clinical practice to inspect these devices prior to use on a patient.The proximal infusion port should be turned off to the patient, by stopcock position or pausing the pump, before cardiac output measurements are attempted.In this instance, it appears that a bolus was pushed through while infusing medication, which could cause a bolus of medication to be delivered to the patient and may have caused the patient¿s blood pressure to change.The swan ganz catheter can be exchanged with a minimal delay in patient care and monitoring.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Possible lot number information: lot 61563690; manufacturing date 11/02/2018; expiration date 10/29/2020; lot 61563689; manufacturing date 11/02/2018; expiration date 10/28/2020; lot 61543343; manufacturing date 10/08/2018; expiration date 10/04/2020.

Manufacturer Narrative

Reference capa-20-00141.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8458688
• MDR Text Key: 140536609
• Report Number: 2015691-2019-01058
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K810352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 831F75
• Device Catalogue Number: 831F75P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR