MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP-I

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

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

Event Date 06/02/2023

Event Type  malfunction  

Manufacturer Narrative

A getinge service technician will investigate the affected cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that the flow bubble sensor cable shield is frayed.The cable was not tested to verify a function failure as it was discovered during initial inspection.No harm to any person has been reported.Complaint id# (b)(4).

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

The information was received on 2023-07-17 that in addition the hls cable is frayed.A getinge field service technician (fst) was sent for investigation and repair on (b)(6) 2023.The flow/bubble sensor was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

It was reported that the flow bubble sensor cable shield and hls cable are frayed.The failures occurred during service.Both cables were not tested to verify a function failure as it was discovered during initial inspection.A getinge field service technician (fst) was sent for investigation and repair on 2023-06-02.The flow/bubble sensor was replaced.The hls cable will be replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The most probable root cause was determined as age-related wear and tear of the cables through frequent flexing and bending over the last years (manufacturing date 2018-08-01).According to the instruction for use (cardiohelp, chapter 5.3 "connection the sensors") it is stated to ensure that the connected sensors are not defective and to not use, if there is a visible damage.The review of the non-conformities has been performed on 2023-06-06 for the period of 2018-08-01to 2023-06-02.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The device was manufactured on 2018-08-01.Based on the results the reported failures "flow/bubble sensor and hls cable frayed" could be confirmed.The customer will be informed about the results by the getinge sales and service unit.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.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.

• Brand Name: CARDIOHELP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, 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: 17059225
• MDR Text Key: 316515400
• Report Number: 8010762-2023-00263
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 701072780
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1