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

Model Number BE-HLS 7050

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was requested but not yet returned.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to ifu the hls set was primed and airless connected to the patient.Sweep gas flow was set to 9 liters of o2.After starting twice, it had massive air intake on the blood side with bubble alarm and stand still of the pump / ecmo.After the second air impact, the system was changed and the ecmo was performed with another set.(b)(4).

Event Description

Ref.: #(b)(4), customer ref(b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary(b)(4).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).The product was returned but was not investigated in the complaints lab because the device may contain biological residue of who risk group 3 considered to be infectious such as hiv, hepatitis a or b.Therefore no laboratory investigation could be performed by the manufacturer.A review for similar complaints (b)(4) to be investigated already was performed with the following outcome: the product was investigated in the laboratory of the manufacturer.The hls set was connected to the cardiohelp device and filled with saline solution.During priming no abnormalities of the de-airing behavior were detected.No air bubbles / accumulation on the arterial side was detected.Based on this a confirmation of the failure was not possible.Since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action is needed at this time the data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7342522
• MDR Text Key: 102743058
• Report Number: 8010762-2018-00095
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Model Number: BE-HLS 7050
• Device Catalogue Number: 701047753
• Device Lot Number: 70119220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Date Manufacturer Received: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1