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

Model Number BE-HQV 30517

Device Problem Restricted Flow rate (1248)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

Further perfusion and patient data was requested but not yet received.A follow-up emdr will be submitted when additional information becomes available.

Event Description

The customer reported increasing resistance of three oxygenators in a row needing replacement during treatment.No indication of actual or potential for harm or death.Complaint id: (b)(4).

Event Description

Complaint #: (b)(4).

Manufacturer Narrative

It was reported that due to increasing resistance pressure in quadrox-id adults the oxygenator was exchanged several times during treatment.No harm or death was reported.It was also reported that the oxygenators were used in va-ecls with limited use of heparin and acts around 150'', blood flow was between 3-4 lpm.The products are not available for investigation in the laboratory of manufacturer.It was reported that the oxygenators were started to resist at the below times: on 2021-08-19: increasing resistances 07h 16h 19h then change of oxygenator; on 2021-08-20: increasing resistances 07h 17h 21h 23h then change oxygenator; on 2021-08-23: increasing resistances 07h 15h then change oxygenator.Customer observed that the oxygenators started to show a resistance after 7 hours of usage.The information received by getinge sales and service support responsible confirms that reported that oxygenators were used longer than 6 hours.On 2021-08-19: used for 19h; on 2021-08-20: used for 23h; on 2021-08-23: used for 15h.Ifu states the maximum duration of use is 6 hours.The device history records for lot number 92311132 for first be-hqv 30517 and lot number 3000165035 for third be-hqv 30517 were reviewed on 2021-11-16.There are no evidences indicating non-conformance or deviations of the product in question during manufacturing and final release of this specific lot.The lot number for the second be-hqv 30517 was not provided by the customer, therefore no dhr review could be performed.The device history records for all three oxygenators could not be reviewed because the serial numbers on the oxygenators were not provided by the customer.It was further reported that acts were around 150''.However the ifu for (product xxx) state that the act should not fall below 450 s.The anticoagulation amount was not provided by the customer, but it was reported as ¿limited use of heparin¿.Based on the information above, the most probably use(r) error contributed to the failure.No product malfunction could be detected with available information however the complaint could be confirmed since it was detected during patient use and customer had to change the devices.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.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 : 4115.

• Brand Name: TUBING SET
• Type of Device: OXYGENATOR, 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: 12427148
• MDR Text Key: 270043668
• Report Number: 8010762-2021-00484
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K150267
• 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: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2021
• Device Model Number: BE-HQV 30517
• Device Catalogue Number: 701053164
• Device Lot Number: 3000165035 & 92311132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1