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

Model Number BE-HLS 7050#HLS SET

Device Problems Loss of Power (1475); Failure to Prime (1492); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the customer: the customer did not able to priming hls set due to bad tubing.The venous and arterial line was preconnected wrong on the hls module.Red line is inlet and blue line is outlet.The customer cut off one valve on red line due to priming procedure.The customer decided to use new hls set.No patient was involved.(b)(4).

Event Description

Internal reference: (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).Maquet cardiopulmonary gmbh requested the product for investigation.The product was investigated in the laboratory of the manufacturer.Maquet laboratory has performed following on 2018-04-09: during the visual inspection of the delivered hls module was found that the venous and arterial tubing lines are not as specified mounted.The venous and arterial lines were reversed.The venous line (blue = low - oxygen venous blood) must be on the blood inlet side, and the arterial tube line (red = oxygen-rich venous blood) on the blood outlet side of the hls oxygenator.Blood is oxygenated in the oxygenator.Conclusion: the complaint, "exchanged arterial and venous lines", could be confirmed.Mcp opened a nonconformance process in order to investigate the observation and define actions steps (nc-18-04-002).All further actions will be performed out of this internal process.Thus the record will be closed.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: 7369945
• MDR Text Key: 103676630
• Report Number: 8010762-2018-00114
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2019
• Device Model Number: BE-HLS 7050#HLS SET
• Device Catalogue Number: 701047753
• Device Lot Number: 70121101
• Date Manufacturer Received: 03/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1