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

Model Number BEQ-HLS 7050 USA#HL

Device Problem Pressure Problem (3012)

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

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Maquet cardiopulmonary (b)(4) requested the product for investigation but the product was already discarded by the hospital.Therefore no laboratory investigation could be performed by the manufacturer.A review for similar complaints to be investigated already was performed and no similar complaints were found.Thus the reported failure could not be confirmed.Based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction.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.

Event Description

According to the hospital: va pt cannulated with 17french arterial and 25 french multi fenestrated venous cannula.The cardiohelp reads higher post mo (part) pressure than pre mo (pint).Which gave usa -44 reading.Also the venous return pressure (pven) does not match the cannula size to flow rpm.Rpm at 3900 with flow of only 4.5 lpm, only to have -20 venous pressure.They are swapping out hls sets anytime.No harm reported to the pt.Additional information received: customer switched out the hls circuit last night.Unfortunately the hls set was discarded.All three pressures were out of normal.(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 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: 8015158
• MDR Text Key: 125605531
• Report Number: 8010762-2018-00291
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2020
• Device Model Number: BEQ-HLS 7050 USA#HL
• Device Catalogue Number: 701052794
• Device Lot Number: 70125827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2018
• 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
• Patient Outcome(s): Required Intervention