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

Model Number BEQ-HLS 7050 USA

Device Problem Improper Device Output (2953)

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

Event Date 12/21/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the customer: "hls was not providing adequate o2, so they decided to swap out for new hls with no further issues." (b)(4).

Manufacturer Narrative

The product was visually inspected in the laboratory of the manufacturer.On the blood inlet side clots were visible.During rinsing of the product no clots were flushed out.The product was tested for its gas exchange performance (02 and co2 transfer rate) in the laboratory of the manufacturer.The gas exchange performance test meets the specification.The pressure drop test could not be performed as the arterial pressure sensor was providing no value to the cardiohelp unit, therefore it was not possible to observe the pressure drop behavior.For the observed arterial pressure measurement error an additional complaint will be opened in order to track and trend this observation.The customer was complaining about not adequate o2.The reported failure was not reproducible during the performance test; therefore the reported failure cannot be confirmed.A dhr review was performed; no references were found, which are indicating a nonconformance of the product in question.The most probable cause of the reported incident is unknown.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.

Event Description

(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: 6221726
• MDR Text Key: 64060715
• Report Number: 8010762-2017-00003
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K80592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA
• Device Lot Number: 70112101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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