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

Catalog Number 701047753

Device Problem Device Sensing Problem (2917)

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

Event Date 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

They stated that the arterial pressure was 200+ mmhg, internal pressure was 300-400 mmhg and venous pressure was +300 mmhg, however there was no kicking in the venous line, so they suspected there were some problems to the pressure sensors inside the set.They changed to another machine with the same set, the problems were still there.Afterwards, they connected external pressure sensors to the set and pre-oxy pressure was 170 mmhg while post-oxy pressure was 180 mmhg.(b)(4).

Manufacturer Narrative

The investigation has been performed by getinge laboratory on 2019-07-04.The integrated sensor plug and the de-airing membrane were wet (priming solution) on arrival.The connection to the integrated sensor was dried.Subsequently, a water cycle with the hls module and the cardiohelp was set up and connected.No abnormalities were found.Thus the failure could not be confirmed.The most probable root cause is a wet, corroded sensor plug.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Internal ref.#: (b)(4) / onesupport:(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8678912
• MDR Text Key: 147337273
• Report Number: 8010762-2019-00164
• 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,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 701047753
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention