MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number HQV 51202

Device Problems Mechanical Problem (1384); Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2022

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when further information becomes available.

Event Description

It was reported that the venous temperature probe port was not attached to the venous line.When customer started priming the circuit the prime fluid was leaking out of the port where the temperature probe is normally attached.Customer closed off the port with a red bung to stop the leakage.However, customer was unable to measure the venous temperature.The product was used on patient.No harm to any person has been reported.Complaint #(b)(4).

Event Description

Complaint:# (b)(4).

Manufacturer Narrative

A follow up medwatch will be submitted when further information becomes available.Medical device-problem code is changed to mechanical problem since the new information states that the failure was broken temperature probe.H3 other text : the product could not be provided by user.

Event Description

(b)(4).

Manufacturer Narrative

It was reported that there was leakage from reservoir and the temperature sensor was not attached.Customer applied red bung to temperature probe port to close the port and stop the leakage, the small crack was detected at leakage point.Leakage was stopped, however customer was not able to measure the venous temperature.The failure was detected while using the product on the patient.Since the product was discarded by customer, sample investigation could not be performed.Received pictures showed a crack on temperature probe port.The customer used red bung to stop leakage that occurred due to crack.Therefore, the failure could be confirmed.The customer states that there was a crack at temperature probe port and temperature sensor was missing.Received information from customer also states that the yellow cap was on the port.However, according to investigation results in manufacturing, it is unlikely to attach yellow cap without temperature sensor, because there would be a gap between the port and the yellow cap due to size difference.The yellow cap does not fit to the temperature probe port and it will fall off directly before packaging.Since the yellow cap was on the port, it means that the temperature sensor should have been attached.The production history record (dhr) of the affected hqv 51202# pediatric/small adult perfusion with lot# 3000184989 and 02971#reservoir vhk 71000 with lot# 3000180491 were reviewed on 2022-03-11.According to the dhr results, the product hqv 51202# pediatric/small adult perfusion passed the defined manufacturing and final release specifications.Based on these information, it could be conclude that the temperature sensor was assembled to the port and yellow cap was also assembled to the probe.If the operator does not connect the sensor to the port adequately, a crack could occur on port and sensor connection comes loose.As a result of loose connection, it is likely that customer unintentionally took the temperature sensor out with yellow cap.Production employees were informed about the complaint on 2022-03-11.The most probable root cause has been found as production error due to operator failure during assembly of temperature sensor.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.This complaint was found as a single event.The reported crack could be detected during visual control and also during priming of the set.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.H3 other text : the product could not be provided by user.

• Brand Name: TUBING SET
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 13385549
• MDR Text Key: 284631811
• Report Number: 8010762-2022-00024
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K053025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2023
• Device Model Number: HQV 51202
• Device Catalogue Number: 701032773
• Device Lot Number: 3000184989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1