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

Model Number BE-HLS 5050

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Type  malfunction  

Event Description

Order received damaged, delivered (b)(6) 2022.Damaged out of box, tyvek cover has slit in it.Shipping packaging not damaged.Not used on patient.Complaint id: (b)(4).

Manufacturer Narrative

The investigaton of the manufacturer is ongoing.

Manufacturer Narrative

The following complaint information was provided to maquet cardiopulmonary: "order received damaged, delivered (b)(6) 2022.Damaged out of box, item has slit in it.Shipping packaging not damaged.Not used on patient." the affected product was investigated at the laboratory of the manufacturer.The reported failure "slit in it" was confirmed hereby.A slit was detected within the tyvek cover of the hls tub.Furthermore, numerous damages to other packaging components of the set were found, which were documented as follows according to the course of the initial visual inspection: a) slight damage in the form of several dents on the underside of the outer packaging b) in some cases severe damage to the white cardboard box for the intellipack tub.C) detection of damage in the protective box in the form of a hole after opening the box d) damage in the tyvek cover, covering the damage in the overlying protective cardboard according to point c).Damage in the form of a cut approximately 25.5mm long e) damage to the tub floor in the form of cracks.Two radial cracks in the area of two welds.The subsequent inspection of the interior of the tub revealed the following facts.There were no ri-ra clamps or hose ends over the so2 connector of the hls module.The inlay was firmly attached to the tub.The hls module was - according to the specification - firmly fixed with the associated velco straps.The so2 connector's retaining lugs/locking hooks were intact and not deformed.The corresponding adhesive tape was located both under the inlay and under the safety plate.Based on the knowledge gained during the test, it can be assumed that the damage was caused from inside the tub and thus by a component of the hls set.Due to the fact that the hls module was firmly fixed and the damage in the tyvek is in an unusual place, the so2 connector can be ruled out as the cause of the damage with a very high degree of probability.As a result, other composts in the tub, particularly those that could move freely, were considered and compared with the form and severity of the damage in the packaging components.The shape and size of the cut in cardboard and tyvek almost completely fits a wing of the filling mandrel.Therefore, the obvious assumption is that the damage was caused by this wing.Due to the low weight of the filling mandrel and its position in the tub, damage of this magnitude/intensity (penetration of the tyvek cover and cardboard box) is not to be expected.Other circumstances that could have contributed to the damage pattern should be considered in the conclusion.It can be considered that as a result of a strict, possibly multiple external forces (e.G.The set falling on its side/top) resulted in the displacement of almost the entire contents of the tub.The following indications indicate that components were displaced during transport: severe damage to the outer/packaging (white cardboard box) and the tub movement of the hose components in the tub -> abrasion on the inside of the tub tearing off the bag with the vent cap, stress whitening on the placemat bowl.In conclusion, it can be said that in this case there was a chain of events that led to the tyvek cover being damaged.The main trigger for these shifts within the tub is considered to be the external force as a result of a possibly unusual transport load.Several signs of shipping damage should be considered in this case.Thus the reported failure was confirmed.It was most probable caused by multiple external forces which resulted in the displacement of almost the entire contents of the during transport of the product.The exact root cause remains unknown.The investigation results have been forwarded to r&d packaging for evaluation.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.

Event Description

Complaint id: (b)(4).

• Brand Name: HLS SET ADVANCED
• 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: 15937598
• MDR Text Key: 306014844
• Report Number: 8010762-2022-00488
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2023
• Device Model Number: BE-HLS 5050
• Device Catalogue Number: 701069077
• Device Lot Number: 3000261053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1