MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CANNULA & CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number HLS CANNULAE

Device Problem Device Handling Problem (3265)

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

Event Type  malfunction  

Manufacturer Narrative

Due to an disposable survey in the usa following was reported: ¿the return cannulas are 23cm in length.We also use a 23 fr od.On the packaging the length is written very close to the diameter so it can be easily mistaken if you are asked for a 23fr cannula and you see a 23 on the packaging but it¿s the length.This happened once where the wrong size cannula was inserted in a patient because a 23 was requested.¿ no harm to any person was reported.The sample is not available for this complaint.The lot number of product was not provided by the customer.Therefore, dhr (production records) review could not be performed.The cannulas with 23 od (outer diameter) and 23 cm length are written on both sterile package and outer (box) package of cannulas.The reference number of the product is written as 2323 on the label.However, on both labels, the od is also written with mm unit as: 23 fr (7.7 mm) on next line of the label the length is also written as: insertion length 23 cm.The labels of 23 fr od and 23 cm length hls cannulas are elaborated in regards to recognize length and diameter sizes.The reported failure is also covered in ifu (instruction for use) of hls cannula: "observe all information on the device." "carefully select the appropriate size of cannula for the particular patient.Determine the vessel diameter, if necessary." "before cannulation, the physician must ensure that the vessel diameter is large enough to allow adequate perfusion of the extremities." "caution! look out for signs of insufficient perfusion of the extremities." based on the information above, the product problem could not be confirmed.It is possible that due to a user error there was a confusion between od and length.And, therefore, the wrong product was used on a patient.The labels are elaborate od and length.No product problem could be confirmed.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.

Event Description

Due to an disposable survey in the usa following was reported: ¿the return cannulas are 23cm in length.We also use a 23 fr od.On the packaging the length is written very close to the diameter so it can be easily mistaken if you are asked for a 23fr cannula and you see a 23 on the packaging but it¿s the length.This happened once where the wrong size cannula was inserted in a patient bc a 23 was requested.¿ complaint #: (b)(4).

• Brand Name: CANNULA & CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, 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: 17629348
• MDR Text Key: 322029914
• Report Number: 8010762-2023-00422
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2023

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 Model Number: HLS CANNULAE
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1