MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number MCP00706291#ROTAFLOW PUMP MODULE

Device Problem Break (1069)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in china.It was reported that the closing assy on the rotaflow drive was broken during patient treatment as the customer renewed the contact creme.The customer fastened the closing assy with tape and the treatment was continued.No harm to any person has been reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the closing assy on the rotaflow drive (rfd) was broken during patient treatment as the customer renewed the contact creme.The customer fastened the closing assy with tape and the treatment was continued.No harm to any person has been reported.The affected device with s/n (b)(6) was investigated by a getinge field service technician.The technician was able to confirm the reported failure.The rfd closing assy needs to be replaced.The affected rotaflow drive is currently out of use.The root cause could be determined as the closing assy broke off due to renewing the contact creme by the customer during treatment.The reported failure "closing assy broken" was already investigated by our lce in a similar complaint.Most probable root causes could be determined: too excessive force weakening due to manufacturing errors (air inclusions) weakening due to aging.Uv light (sun) or contact with chemicals.Based in the information available at this time the reported failure "closing assy broken" could be confirmed.The review of the non-conformities has been performed on 2023-04-25 for the period of 2013-08-10 to 2023-02-14.It does not show any non-conformity in regard to the reported product and failure.There is no indication on manufacturing issues occurred during this time, thus production related influences are unlikely.The product in question was produced in 2013-08-10.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.4 | en | chapter 2.2.2 position of use and operation, and positioning do not remove the disposable during the application.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: HEART LUNG MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: 16441750
• MDR Text Key: 310274378
• Report Number: 8010762-2023-00100
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706291#ROTAFLOW PUMP MODULE
• Device Catalogue Number: 701046405
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1