MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IT MONITORING KIT 60" PRESS TUBING, 3ML FLUSH DEVICE, UNBOND MACRODRIP; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number 42594-05

Device Problem High Readings (2459)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The event occurred in the neurological critical care unit (nccu) and involved a transpac® iv monitoring kit w/4 way stopcock, 3 way stopcock and 24" arterial pressure tubing used on a patient requiring ¿hvis¿ treatment for severe symptomatic vasospasm.Due to this, the patient needed arterial line monitoring to manage vasopressors for a systolic blood pressure (sbp) 160-200 goal.After the device was in use for ten minutes, the monitor indicated that the patient¿s arterial line began to display blood pressure readings markedly out of proportion to the bp cuff pressure with a diastolic blood pressure (dbp) that did not correlate with the patient¿s clinical picture (dbp >140).It was reported that the arterial line exhibited good blood return and an adequate waveform, and given this, the patient was treated for an elevated dbp.The readings continued to be abnormally out of range so troubleshooting the arterial line continued.The tubing and transducer were replaced, and this resulted in a reading that immediately correlated with the cuff¿s reading.As a result, it was determined that the likely source of the incident was the tubing transducer itself.Once an appropriate waveform was obtained, the patient was found to be profoundly hypotensive, with an sbp of <70.The patient was immediately restarted on two unspecified vasopressor medications, and the patient¿s blood pressure gradually returned to the desired goal range.There was patient involvement and although a delay in therapy was reported, no adverse event and no harm was reported by the customer.

Manufacturer Narrative

The device has been received and an evaluation is pending.D9 date returned to mfg - february 5, 2021.Additional information can be found in sections a1, a2, a4, b5, b6, b7, d1, d4, and g4.

Event Description

The customer described that the transducer set up was typical and that there were no obvious defects observed on the transpac monitoring kit.Levophed and phenylephrine was being given to the patient.

Manufacturer Narrative

One used partial transpac¿ it monitoring kit, 60" pressure tubing, 3ml flush device, un-bonded macrodrip was received for investigation.The reported complaint of cannot obtain readings was confirmed on the returned sample.A sample image was provided by the customer showing the involved product.A failure mode was not able to be identified with the the image that was provided by the customer.No visual anomalies were observed on the returned set.When the transducer was electrically tested, it was not able to be zeroed.When the set was hydrostatically pressure leak tested and no leaks were observed.The reported sample was sent to the vendor for extended investigation.According to the vendor, a probable cause for cannot obtain readings had occurred due to non stick wire on die pad or ceramic pad.However, when the damage had occurred to the sensor is unknown.A device history record (dhr) review could not be conducted because no lot number was identified.

• Brand Name: TRANSPAC IT MONITORING KIT 60" PRESS TUBING, 3ML FLUSH DEVICE, UNBOND MACRODRIP
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 11275535
• MDR Text Key: 230687732
• Report Number: 9617594-2021-00027
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 42594-05
• Device Catalogue Number: 42801-03
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEVOPHED, MFR UNK; MANUAL BLOOD PRESSURE CUFF, MFR UNK; PHENYLEPHRINE , MFR UNK
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 46