MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IV W/3-WAY STOPCOCK AND 30" PRESSURE TUBING; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 46116-64

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

The used device and a new device from a different lot number were received for evaluation.The investigation is pending.

Event Description

The customer reported a transpac iv w/3-way stopcock and 30¿ pressure tubing that stopped monitoring during a triple coronary bypass surgery.A high pressure caused a false reading and then causing the arterial pump to stop the extra-body circulation.Despite re-plugging the sensor and re-zeroing again, high pressure reading alarm was indicated.The arterial pump refusing to operate, so they had to use the emergency crank while the defective transducer was switched with a new one.The mating device is the arterial pump¿s head, which is related to the monitoring.The product was used on a patient at the time of the incident with a delay in critical therapy.The patient was stable before, during, and after the event.

Event Description

Additional information received that there was no significant impact over the surgery time, as the time it took to change the transducer was 5 to 10 minutes.

Manufacturer Narrative

H10: one (1) used partial list#: 46116-64, transpac® iv w/3-way stopcock, and 30" pressure tubing; lot#: 4351116 and one (1) new list#: 46116-64, transpac® iv w/3-way stopcock, and 30" pressure tubing; lot#: 4330223 were received for evaluation.The 30¿ high pressure tubing was not returned on the used set.The reported complaint of transducer stopped working was confirmed on sample 1, the used device, and not confirmed on sample 2, the new device.No visual anomalies were observed on sample 2.During visual inspection on sample 1, corrosion was observed on the tpiv connector.The probable cause of the corrosion on tpiv connector had occurred due to a fluid ingress in the tpiv connector during use.The transducers of both the samples were electrically tested.The transducer of sample 2 was able to obtain a wave form and was able to be zeroed with the waveform visible on the monitor.No interruptions were observed on the wave form when the cable was twisted or bent.Sample 2 had performed per the product specifications.Sample-1 was not able to zero and a wave form was not obtained.The set was primed and pressure leak tested and no leaks were observed externally on the set.When the transpac was cut open, drops of water splashed out of the blue housing.Corrosion was observed inside the blue housing.A part of the gel cup got inside the blue housing through the walls of the microchip.This could lead the transducer to stop monitoring.The probable cause of the gel cup which got inside the microchip had occurred due to over pressurizing of the set during use.The device history review for lot numbers: 4351116 and 4330223 were reviewed and there were no relevant non-conformances found.

• Brand Name: TRANSPAC IV W/3-WAY STOPCOCK AND 30" PRESSURE TUBING
• 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: 10201025
• MDR Text Key: 202947590
• Report Number: 9617594-2020-00203
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00887709089983
• UDI-Public: (01)00887709089983(17)220901(10)4351116
• Combination Product (y/n): N
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 46116-64
• Device Lot Number: 4351116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1