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

Model Number BEQ-HLS 7050 USA

Device Problems Migration or Expulsion of Device (1395); Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device in question was requested for investigation but has not been received.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

While priming a cardiohelp hls set, one-way valve in arterial limb of prime bag allowed small amount of prime fluid to migrate backwards.Line was clamped until ready for recirculation, priming finished and prime set disconnected from patient circuit without incident.One-way valve did not prevent retrograde flow.This occurred prior to patient use with no negative patient outcome.(b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) received the product back for laboratory investigation.During investigation the one-way-valve was removed from set, cleaned and disinfected.A tightness test on valve was performed.It was detected, that the sealing lip locks did not tighten enough.Thereby a minor amount of fluid was able to run back.Complaint could be confirmed.For further investigation a device history record was performed by the manufacturer on 10/08/2015.No abnormalities has been found.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

(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): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5035723
• MDR Text Key: 25062188
• Report Number: 8010762-2015-01023
• 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: Followup
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 70100127
• Device Lot Number: 70100127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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