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

Model Number CARDIOHELP-I

Device Problem Increase in Pressure (1491)

Patient Problem Hematoma (1884)

Event Date 10/04/2021

Event Type  Injury  

Manufacturer Narrative

A follow up will be submitted, when additional information become available.A getinge technician will investigate the unit in question.Medical experts will investigate the reported event.More detailed information were requested, answers still pending.

Event Description

High negative pressure of the cardiohelp during treatment was reported.Information received: "patient harmed, sever hematoma".More detailed information requested, but answer still pending.Complaint number: (b)(4).

Event Description

Complaintnumber: (b)(4).

Manufacturer Narrative

It was reported that there was a high negative pressure on the cardiohelp.A severe hematoma was reported.On 2021-10-12 it was confirmed by customer, that the patient hematoma was not caused by the cardiohelp.The customer stated that the cardiohelp pump and hls circuit performed exactly as expected.The reason for complaining was to pull the alarms and settings logs from the pump for their own internal understanding of the pump settings during the treatment of the patient.A getinge service technician was sent for investigation on 2021-12-20.He performed a preventive maintenance as per service manual and could not confirm any malfunctions.The device was tested and was cleared for clinical use.No parts needs to be replaced.The logfiles of the cardiohelp were analysed by getinge technical experts on 2021-12-24.No malfunction could be confirmed.A medical review was performed by getinge medical experts on 2021-11-07 with the following outcome: as mentioned in the body of the complaint, the clinical staff indicated that the complaint was generated with the intent to gain access to the cardiohelp data log.Further, the expectation was that the data log might provide insight into the event within the narrative of this complaint (i.E.The generation of the hematoma).It seems clear that the complaint did not pertain to the function or performance of cardiohelp or to its associated disposable per se, but to a request for the internal data log.Moreover, both cardiohelp and the hls disposable were described (in the complaint) as functioning as expected.It may be reasonably assumed, therefore, that the event reported by the customer (i.E.The generation of a hematoma) was not the result of a malfunction or diminution in performance of the device (cardiohelp) or its related disposable (hls set).Thus the reported serious injury cannot be related to the reported complaint.An exact root cause for the reported failure "high negative pressure" could not be identified, however, with reference to the current risk file of the cardiohelp most possible causes could be linked to the reported event: - defibrillator system; - laser scalpel; - connection of non-capatible senor; - response time is too long; - positive or negative pressure beyond specification (release of tubes); - too high / low atmospheric pressure.The device history record (dhr) of the cardiohelp (material: 701072780, serial: (b)(6), elo#: 1095959/v1) was reviewed on 2022-01-03.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on the investigation results, the reported failure "high negative pressure" could not be confirmed.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: 12603644
• MDR Text Key: 275842262
• Report Number: 8010762-2021-00548
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• 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: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other