MAUDE Adverse Event Report: RICHARD WOLF GMBH HYSTERO PUMP; IRRIGATION PUMP

Model Number 2222.001

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Pulmonary Edema (2020); Low Oxygen Saturation (2477); No Code Available (3191)

Event Date 02/15/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is on-going.A follow up will be submitted upon receipt of additional information.

Event Description

On march 24, 2020, richard (b)(4) received the following information: a patient with uterine fibroids was sent to the operating room at 8:30 am.On (b)(6) 2020.A hysteroscopy and submucosal myomectomy under intravenous anesthesia.The operation started at 9:10 am.The instrument was connected and the pressure of the irrigation pump was adjusted to 90mmhg.The blood oxygen saturation of the patient decreased from 100% to 90% at 10:10 am.A large number of moist rales were heard during auscultation of both lungs and the operation was stopped because of the acute pulmonary edema caused by the over-rapid injection of irrigation pump.Oxygen inhalation, by mask, 20mg diuretic administration of furoxime was administered to reduce cardiac load, and 15mg intravenous administration of dexamethasone to improve pulmonary capillary permeability.At 10:12 am, the patient developed a cough of pink sputum in the mouth, sputum aspiration, half supine sitting position, insertion of urine tube to record the volume, and 20 minutes after the repeated use of furoxime 20mg twice.At 10:30 pm., the patient was awake, complaining of cough and phlegm discomfort.At 11:05 pm, it was noted that the patient's condition had gradually improved, with oxygen saturation rising above 98%, the moist rales of both lungs were reduced.The patient was still in critical condition and might have further deterioration at any time.The patient was transferred to the intensive care department for further observation and treatment.

• Brand Name: HYSTERO PUMP
• Type of Device: IRRIGATION PUMP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 9922561
• MDR Text Key: 191016053
• Report Number: 9611102-2020-00002
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K022449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2222.001
• Device Catalogue Number: 2222.001
• Date Manufacturer Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention