MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Contact person- (b)(6).The 3 hls sets were returned for further investigation at maquet laboratory.According to investigation report: during visual inspection it has been detected that at all 3 beutel reservoirs the wrong luer lock has been connected to the de-airing tube.Therefore de-airing of the priming-bags ((b)(6), material# (b)(4)) are not possible.Thus the failure could be confirmed.A capa has been initiated on 2018-05-16.Further investigation will be handled within the capa (b)(4).On 2018-07-27: during (b)(4) the issue has been evaluated by maquet clinical risk management with following result: due to possible delay of treatment, caused by the replacement of the set, there will be a risk to the patient in case of recurring.

Event Description

As stated by the customer: during priming hospital noticed that the de-airing tube from the primebag is closed.There are 3 sets with the same issue and the same lot number.The hls sets were replaced during priming.No patient involvement.(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 7735191
• MDR Text Key: 115774679
• Report Number: 8010762-2018-00237
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: BE-HLS 7050
• Device Catalogue Number: 701047753
• Device Lot Number: 70120207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1