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

Model Number BEQ-HLS 7050 USA#HL

Device Problem Material Perforation (2205)

Patient Problem Hypoxia (1918)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was reported that a hole in the green gas tube was discovered.The patient was cannulated on (b)(6) 2018 and the leak was discovered on (b)(6) 2018.Patient was experiencing persistent hypoxia.The patient was having increasing co2 levels therefore the nurses did a repeat circuit check and thought they heard extra air.They submerged the tubing in a water bath and found a hole midway down the tubing.Because of the location of the hole, cutting the tubing length too short so the nurse tried wrapping the hole in tape.It was not successful.At that point they switched to tubing from another hls set to replace the one with hole so they can use the hls.Patient issue was resolved once they replaced tubing from another set.No harm to patient was reported.(b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- (b)(4).The affected sample was received by manufacturer laboratory for investigation.Since the declaration of infection risk (doir) is missing we are not allowed to open the biocontainer, to take out the sample for investigation.Despite several requests the doir has not been sent by the ssu.Therefore no investigation is possible.The failure could not be confirmed.According to the statement from 2018-06-14 from our chief medical officer: "of course, a hole in the gas tube makes itself felt rather sooner rather than after a week.In that sense, i can not believe that this hole existed from the beginning.The customer himself noticed so obviously changed co2 values only after several days and thus this story is not credible." since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.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

Internal reference: (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
• MDR Report Key: 7669669
• MDR Text Key: 113642015
• Report Number: 8010762-2018-00224
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2020
• Device Model Number: BEQ-HLS 7050 USA#HL
• Device Catalogue Number: 701052794
• Device Lot Number: 70123177
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention